DECEMBER
2008
WEEK ENDING DECEMBER 6
PRODUCT
a) Axiom Artis
dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807,
b) Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray
System, Model number 5917054, c) Axiom Artis dTA,
Axiom Artis Modular Angiography X-Ray System, Model number 7008605,
d) Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray
System, Model number 7413078,
e) Axiom Artis dBA,
Axiom Artis Modular Angiography X-Ray System, Model number 7555357,
f) Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray
System, Model number 7727717, g) Axiom Artis dFA,
Axiom Artis Modular Angiography X-Ray System, Model number 7555373,
h) Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray
System, Model number 7555365,
i) Axiom Artis dBC,
Axiom Artis Modular Angiography X-Ray System, Model number 7728392.,
CODE
a) Serial numbers: 34999, 35049, 35097,
35184, 35235, 35248, 35273, 35286, 35505, 35656, 35705, 35706, 35711, 35726,
35728, 35737, 35740, 35751, 35759, 35760, 35761, 35762, 35763, 35765, 35766,
35769, 35770, 35771, 35773, 35774, 35775, 35776, 35777, 35778, 35779, 35781,
35782, 35783, 35784, 35785, 35786, 35787, 35788, 35789, 35790, 35791, 35792,
35793, 35794, 35795, 35796, 35797, 35798, 35799, 35800, 35801, 35802, 35803,
35804, 35805, 35806, 35807, 35808, 35809, 35810, 35811, 35812, 35813, 35815,
35816, 35817, 35818, 35819, 35820, 35821, 35822, 35823, 35824, 35825, 35826,
35827, 35828, 35829, 35830, 35831, 35832, 35833, 35834, 35835, 35836, 35837,
35838, 35839, 35840, 35841, 35842, 35843, 35844, 35845, 35846, 35847, 35848,
35849, 35852, 35854, 35855, 35856, 35857, 35858, 35859, 35861, 35862, 35863,
35864, 35865, 35866, 35867, 35868, 35869, 35870, 35871, 35872, 35873, 35874,
35875, 35876, 35877, 35879, 35880, 35881, 35882, 35883, 35884, 35885, 35886,
35887, 35888, 35890, 35891, 35892, 37701, 37713, 37714, 37715, and 37716;
b)
Serial numbers: 49001, 49008, and 49009;
c) Serial numbers: 55001, 55003,
55019, 55021, 55036, 55037, 55043, 55048, 55138, 55162, 55166, 55181, 55242,
55255, 55264, 55266, 55278, 55280, 55288, 55298, 55323, 55333, 55341, 55347,
55349, 55350, 55351, 55358, 55361, 55368, 55377, 55378, 55386, 55396, 55397,
55399, 55402, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416,
55417, 55418, 55419, 55420, 55421, 55422, 55423, 55424, 55425, 55426, 55427,
55428, 55429, 55430, 55431, 55432, 55433, 55434, 55435, 55436, 55437, 55438,
55439, 55440, 55441, 55442, 55443, 55444, 55445, 55446, 55447, 55448, 55449,
55450, 55452, 55453, 55454, 55455, 55456, 55457, 55458, 55459, 55460, 55461,
55462, 55463, 55464, 55465, 55466, 55467, 55468, 55470, 55471, 55472, 55473,
55474, 55476, 55477, 55478, 55479, 55480, 55481, 55482, 55483, 55484, 55485,
55486, 55487, 55488, 55489, 55490, 55492, 55493, 55494, 55495, 55496, 55497,
55498, 55499, 55500, 55501, 55502, 55503, 55504, 55506, and 55507;
d) Serial
numbers: 46129, 46189, 46190, 46206, 46208, 46209, 46210, 46211, 46212, 46213,
46214, 46215, 46216, 46217, 46218, 46219, 46220, 46221, 46222, 46223, 46224,
46225, 46226, 46227, 46228, 46229, 46230, 46231, 46232, 46233, 46234, 46235,
46236, 46237, 46238, 46239, 46241, 46242, 46243, 46244, 46245, 46246, 46248,
46249, 46250, 46251, 46253, 46254, and 46255;
e) Serial numbers: 53002,
53007, 53008, 53027, 53028, 53030, 53031, 53032, 53046, 53059, 53079, 53089,
53090, 53091, 53092, 53105, 53106, 53112, 53122, 53125, 53127, 53129, 53134,
53137, 53148, 53151, 53157, 53158, 53163, 53167, 53168, 53169, 53170, 53180,
53182, 53183, 53184, 53185, 53187, 53188, 53189, 53190, 53191, 53192, 53193,
53195, 53196, 53197, 53199, 53200, 53201, 53202, 53203, 53204, 53205, 53206,
53207, 53208, 53209, 53210, 53211, 53212, 53213, 53215, 53216, 53217, 53218,
53219, 53220, 53221, 53222, 53223, 53224, 53225, 53226, 53227, 53228, 53229,
53231, 53232, 53233, 53234, 53235, 53237, 53238, 53239, 53240, 53706, 53707,
53708, 53709, 53710, and 53711;
f) Serial numbers: 40000, 40061, 40062,
40063, 40064, 40065, 40066, 40067, 40069, 40070, and 40071;
g) Serial
numbers: 50080, 50135, 50137, 50138, 50139, 50140, 50141, 50142, 50143, 50144,
50145, 50146, 50147, 501 48, 50149, 50151, 50152, 50153, 50154, 50155, 50156,
50157, 50158, 50159, 50160, 50161, 50163, 50164, 50165, 50166, 50167, 50169,
50170, 50171, 50172, 51708, 51709, 51710, 51711, 51712, and 51713;
h) Serial
numbers: 57001, 57002, 57093, 57103, 57119, 57122, 57132, 57133, 57134, 57135,
57136, 57137, 57139, 57140, 57141, 57143, 57144, 57145, 57146, 57147, 57148,
57149, 57150, 57151, 57152, 57153, 57154, 57156, 57157, 57158, 57159, 57160,
57161, 57162, 571 63, 57164, 57165, 57166, 57167, 57168, 57169, 57170, 57171,
57172, 57173, 57174, 57175, 57177, 57178, 57179, 57181, 57182, 57183, 57184,
57185, and 57186;
i) Serial numbers: 44075, 44077, 44084, 44240, 44262,
44265, 44267, 44268, 44269, 44270, 44271, 44272, 44273, 44274, 44275, 44276,
44277, 44278, 44279, 44280, 44281, 44282, 44283, 44284, 44285, 44286, 44287,
44288, 44289, 44290, 44291, 44292, 44293, 44294, 44295, 44296, 44298, 44299,
44300, 44302, 44303, 44304, 44305, 44306, 44307, and 44308
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc., Malvern, PA,
Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany.
REASON Incorrect contour finding: Image may be
calibrated to the wrong size catheter.
VOLUME OF PRODUCT IN
COMMERCE 577
units
DISTRIBUTION Nationwide
PRODUCT
1) PREMISE, Part No. 32650, 10 PACK UNIDOSE PREMISE A1, dental
composite,
2) PREMISE, Part No. 32651, 10 PACK UNIDOSE
PREMISE A2, dental composite,
3) PREMISE, PART NO.
32652, 10 PACK UNIDOSE PREMISE A3, dental composite,
4) PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite,
5) PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE
A4, dental composite,
6) PREMISE, PART NO. 32655, 10
PACK UNIDOSE PREMISE B1, dental composite,
7) PREMISE,
PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite,
8) PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental
composite,
9) PREMISE, PART NO. 32658, 10 PACK UNIDOSE
PREMISE B4, dental composite,
10) PREMISE, PART NO.
32659, 10 PACK UNIDOSE PREMISE C1, dental composite,
11) PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite,
12) PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE
C3, dental composite,
13) PREMISE, PART NO. 32662, 10
PACK UNIDOSE PREMISE C4, dental composite,
14)
PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite,
15) PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental
composite,
16) PREMISE, PART NO. 32665, 10 PACK
UNIDOSE PREMISE D4, dental composite,
17) PREMISE,
PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite,
18) PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2,
dental composite,
19) PREMISE, PART NO. 32668, 10 PACK
UNIDOSE PREMISE A2 OPAQUE, dental composite, 20)
PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite, 21) PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE
A3.5 OPAQUE, dental composite,
22) PREMISE, PART NO.
32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite, 23) PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE,
dental composite, 24) PREMISE, PART NO. 32674, 10 PACK
UNIDOSE PREMISE C2 OPAQUE, dental composite, 25)
PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite,
26) PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE
TRANS GREY, dental composite,
27) PREMISE, PART NO.
32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite,
28) PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE,
dental composite, 29) PREMISE, PART NO. 32811, 10 PACK
UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite,
30) PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL
ONLY), dental composite,
31) PREMISE, PART NO. 32813,
10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite,
32) PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5
(INTERNATIONAL ONLY), dental composite,
33) PREMISE,
PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental
composite,
34) PREMISE, PART NO. 32817, 10 PACK
UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite,
35) PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL
ONLY), dental composite,
36) PREMISE, PART NO. 32822,
10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite,
37) PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4
(INTERNATIONAL ONLY), dental composite,
38) PREMISE,
PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental
composite,
39) PREMISE, PART NO. 32830, 10 PACK
UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite,
40) PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT
AMBER (INTERNATIONAL ONLY), dental composite,
41)
PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite,
42) PREMISE KIT, Part No. 33882, Unidose Premise Mini
Kit, dental composite,
CODE
1) Lot
Number’s: 2981424, 3001270, 3001273, 3027780, and 3031654;
2) Lot Number’s:
2981427, 2990911, 2997977, 3001277, 3018924, 2983068, 2991212, 3001276, 3008211,
3018925, and 2990753;
3) Lot Number’s: 2989376, 2998295, 3027232, 3032714,
2979610, 2992904 3001278, 3032367, 2961138, 2999887, and 2994827;
4) Lot
Number’s: 3001279, 3001280, 3027784, 3031663, and 3045735;
5) Lot Number’s:
300128, and 3031666;
6) Lot Number’s: 2981430, 3001285, 3001286, and
3001288;
7) Lot Number’s: 3001289, and 3001290;
8) Lot Number’s: 3001292,
and 3001293;
9) Lot Number’s: 3001295, and 3001296;
10) Lot Number’s:
2999213, 2999888, 3001298, and 3032735;
11) Lot Number: 3001299;
12) Lot
Number’s: 2999220, 3001301, 3001302, 3018174, and 3031244;
13) Lot Number’s:
3001304, 3001305, 3019086, and 3032740;
14) Lot Number’s: 3001306, 3001307,
and 3001308;
15) Lot Number’s: 3001309, 3001311, and 3032745;
16) Lot
Number’s: 2999264, and 3028525;
17) Lot Number’s: 3001312, 3001313, and
3009770;
18) Lot Number’s: 3001314, and 3027204;
19) Lot Number’s:
3001335, 3001336, and 3032769;
20) Lot Number: 3001338;
21) Lot Number:
3001339;
22) Lot Number’s: 3001341, and 3001342;
23) Lot Number:
3001343;
24) Lot Number’s: 3001345, and 3001346;
25) Lot Number’s:
3015352, and 3001330;
26) Lot Number: 3001332;
27) Lot Number’s: 3001334,
and 3018923;
28) Lot Number: 2990913;
29) Lot Number’s: 3001316, and
3011566;
30) Lot Number’s: 3001318, and 3018916;
31) Lot Number’s:
3001320, and 3018915;
32) Lot Number’s: 3001322, and 3018914;
33) Lot
Number’s: 3001323, and 3001324;
34) Lot Number: 3001326;
35) Lot Number:
3001327;
36) Lot Number: 3034871;
37) Lot Number: 3001328;
38) Lot
Number: 3018912;
39) Lot Number: 3001351;
40) Lot Number’s: 3001347, and
3016070;
41) Lot Number’s: 3000205, and 3013662;
42) Lot Number’s:
2989348, 2993142, 2993144, 3004342, 3028177, 2993141, 2993143,
RECALLING FIRM/MANUFACTURER Kerr Corporation, Orange,
CA,
REASON Material stiff: Material in several lots
of Premise Unidose appears to stiffen and become difficult to extrude over
time.
VOLUME OF PRODUCT IN COMMERCE
22,478
packs
DISTRIBUTION Nationwide, Australia, Canada, Hong
Kong, Malaysia, Mexico and
Singapore
PRODUCT
Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number:
339001ND, Intended to open the UNI-Compression Plate olive, which creates a
compression,
CODE Lot numbers: E6WS,
E7UY and E86M
RECALLING FIRM/MANUFACTURER
Recalling
Firm:
Integra LifeSciences Corporation, Plainsboro, NJ,
Manufacturer:
NewDeal SA, Lyon, France.
REASON Reports of the Uni-CP Compression Forceps
breaking during the Compression of the Uni-CP plate.
VOLUME OF
PRODUCT IN COMMERCE 90
units
DISTRIBUTION Nationwide
PRODUCT
a) Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat
panel/digital imager). Model number 10252047. Universal fluoroscopic x-ray
diagnostic system,
b) Axiom Luminos dRF without ST
filter. Solid state x-ray imager (flat panel/digital imager). Model number
10252048. Universal fluoroscopic x-ray diagnostic system,
CODE
a) Serial Numbers: 10017, 10044, and
10049;
b) Serial Number: 10046
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc., Malvern, PA,
Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany. .
REASON Issue may occur where an intended
movement of the joystick may unintentionally initiate an x-ray
exposure.
VOLUME OF PRODUCT IN COMMERCE
4
units
DISTRIBUTION Nationwide
PRODUCT
"LOCATOR
Abudment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is
sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant.
The product is used with supra-gingival, universal hinge, resilient overdenture
attachment for endosseous implants,
CODE
Product Codes: 8190 (1.0 mm), 8191 (2.0
mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195
(6.0mm)
RECALLING FIRM/MANUFACTURER
Zest Anchors, Inc.,
Escondido, CA, by letter on April 23, 2008. Firm initiated recall is complete.
REASON The recall was initiated after the firm
discovered through a customer complaint that the Locator Abutments for 5.7
Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer
Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11,
TSV6B13, TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator
Abutment bottoms out in the pilot hole of these implants causing up to a half
millimeter gap between the seating surface of the Locator Abutment and the
implant. This gap in the fit could allow bacteria to enter into the implant
body, contaminating the implant, or allow screw loosening with the risk of
abutment fracture.
VOLUME OF PRODUCT IN COMMERCE 996
units
DISTRIBUTION Nationwide, Spain, Canada, Australia
and South
Africa
PRODUCT
a)
Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN
MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520.
Indicated for use endoscopically or percutaneously to retrieve tissue sampling
of soft organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate,
b) Boston Scientific Easy Core" Biopsy
System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene
oxide gas . UPN for inner pouch M001434500 Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited to,
organs such as breast, liver, kidney or prostate,
c)
Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN
M001434511, Sterilized with ethylene oxide gas. UPN for inner pouch M001434510.
Indicated for use endoscopically or percutaneously to retrieve tissue sampling
of soft organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate,
d) Boston Scientific Easy Core" Biopsy
System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide
gas. UPN for inner pouch M001434530. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited to,
organs such as breast, liver, kidney or prostate,
e)
Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN
M001434541, Sterilized with ethylene oxide gas. UPN for inner pouch M001434540.
Indicated for use endoscopically or percutaneously to retrieve tissue sampling
of soft organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate,
f) Boston Scientific Easy Core" Biopsy
System, 15 ga. x 10 cm, REF 43-456, UPN M001434561, Sterilized with ethylene
oxide gas. UPN for inner pouch M001434560. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited to,
organs such as breast, liver, kidney or prostate,
g)
Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN
M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570.
Indicated for use endoscopically or percutaneously to retrieve tissue sampling
of soft organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate,
h) Boston Scientific Easy Core" Biopsy
System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, Sterilized with ethylene
oxide gas. UPN for inner pouch M001434580. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited to,
organs such as breast, liver, kidney or prostate,
i)
Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN
M001434591, Sterilized with ethylene oxide gas. UPN for inner pouch M001434590.
Indicated for use endoscopically or percutaneously to retrieve tissue sampling
of soft organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate,
j) Boston Scientific Easy Core" Biopsy
System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, Sterilized with ethylene
oxide gas. UPN for inner pouch M001434600. M001434601 43-460 Indicated for use
endoscopically or percutaneously to retrieve tissue sampling of soft organs,
tumors or masses for histological analysis. Soft tissue sampling includes, but
is not limited to, organs such as breast, liver, kidney or prostate,
CODE
a) Lot #’s: 11516922, 11532173,
11547760, and 11569929;
b) Lot #’s: 11524375 and 11535831;
c) Lot #’s:
11532167 and 11554902;
d) Lot #’s: 11520532, 11539484, 11579252, and
11642796;
e) Lot #’s: 11520676 and 11551300;
f) Lot #43-456;
g) Unit:
11546134;
h) Units: 11516921 and 11550539;
i) Units: 11518343, 11535832,
and 11634771;
j) Unit: 11520769
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation,
Maple Grove, MN,
Manufacturer: Boston
Scientific Corporation, Spencer, IN.
REASON Boston Scientific Corporation initiated a
recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the
cannula latch on the device. This difficulty may result in an inability to use
the device.
VOLUME OF PRODUCT IN COMMERCE
3,808
units
DISTRIBUTION Nationwide
PRODUCT
Fredrick’s Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic
retractor used in plastic surgery procedures to retract tissue,
CODE
Lot #: 042408D08
RECALLING
FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL,
REASON
Fiber optic cable is missing from the
Frederick’s Converse Retractor.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION Nationwide
Terumo Cardiovascular Systems Issues Recall of Pediatric Arterial Cannulae
Terumo Cardiovascular Systems (Terumo CVS) is issuing a recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.
|
Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected | |
|
Catalog Number |
Lot Number |
|
813568 |
0501639, 0512002 |
|
813567 |
0501557, 0512008 |
|
813570 |
0502200, 0513069 |
|
813569 |
0502199, 0513068, 0517852 |
|
813572 |
0507121, 0512918 |
|
813571 |
0507120, 0512919, 0518680 |
|
813574 |
0509240 |
|
813573 |
0509238, 0517874 |
|
813576 |
0509241 |
|
813575 |
0500759, 0513331 |
|
813578 |
0500760 |
|
813577 |
0502878 |
An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.
Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.
For more information, visit http://www.terumo-cvs.com/.
WEEK ENDING DECEMBER 13
PRODUCT GSI Audera (version 2.6 software)
Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705,
2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an
audiometric test battery. It can be used to assess cochlear function, enable
estimation of behavioral hearing thresholds by evoking auditory brainstem or
steady state brainstem response and to aid in detection of lesions in the
auditory pathway on neonates through adults,
CODE
Serial Numbers: AT040554 AT40565 AT040558 AT040560
AT040559 AT040566 AT040564 AT040570 AT040571 AT040591 AT040594 AT040596 AT050606
AT050619 AT040599 AT050622 AT050625 AT050634 AT050639 AT050640 AT050651 AT050654
AT050655 AT050652 AT050653 AT050657 AT050663 AT050674 AT050673 AT050675 AT050682
AT050680 AT050683 AT050708 AT050692 AT050690 AT050706 AT050707 AT050710 AT050732
AT050691 AT050752 AT050755 AT050743/AT050748 AT050765 AT050778 AT050776 AT050782
AT050784 AT050795 AT050801 AT050797 AT050799 AT050786 AT050805 AT050809 AT050812
AT050806 AT050816 AT050819 AT050818 AT050820 AT050829 AT050834 AT050836 AT050842
AT050852 AT050843 AT050855 AT050853 AT060859 AT060892 AT060862 AT060864 AT060868
AT060882 AT060885 AT060886 AT060883 AT060891 AT060894 AT060884 AT060903 AT060904
AT050691P AT060914 AT060911 AT060912 AT060913 AT060892 AT060925 AT060937
AT060926 AT060940 AT060941 AT060942 AT060938 AT060944 AT060945 AT060946 AT060949
AT070205 AT070206 AT070207 AT060938 AT070219 AT070218 AT070226 AT070227 AT070228
AT070230 AT070241 AT070200 AT070253 AF071624 AT070252 AT070257 AT070221 AT070220
AT070269 AT070272 AT070273 AT070274 AT070278 AT070280 AT070290 AT070292 AT070289
AT070299 AT070304 AT070310 AT070307 AT070314 AT070317 AT070333 AT070306 AT070331
AT070339 AT070340 AT070341 AT070350 AT070370 AT070352 AT070257 AT070369 AT070376
AT070360 AT070396 AT080399 20030241 20030338 AT080417 AT070339 AT070318 AT080418
AT080426 and AT080427. Additional serial numbers to be supplied later.
RECALLING FIRM/MANUFACTURER Cardinal Health, Inc.,
Madison , WI ,
REASON GSI
Audera systems require a system software update due to issues with the
Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A.
Split Screen Field Correction: GSI Audera units with version 2.6 software may
mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the
identification of the stimulus ear. When using 2.6 software in split-screen
mode, and switching data acquisition from right ear to the left ear, if the
audiologist clicks back on the right ear to annotate or mark it, the data
acquisition from the left ear is then assigned to the record of the right ear.
The waveform is labeled as a right ear response even though the left ear was
stimulated and vice versa. Mislabeling of the results could lead to a decision
to fit a hearing aid on the incorrect ear and result in excessive hearing aid
amplification and possible damage to the misdiagnosed ear. B. VEMP Marketing
Correction: The US Food and Drug Administration is requiring the removal of the
Vestibular Evoked Myogenic Potential (VEMP) function from the GSI Audera
products in the field until this function has been granted FDA's clearance.
VOLUME OF PRODUCT IN COMMERCE 297 units
DISTRIBUTION Nationwide
PRODUCT Posey Synthetic Leather and Biothane Waist and Wrist Restraints,
Catalog Numbers: 2217SL and 2217B,
CODE All units
RECALLING FIRM/MANUFACTURER
J T
Posey Co., Arcadia , CA ,
REASON Failure to restrain.
VOLUME
OF PRODUCT IN COMMERCE 145 units
DISTRIBUTION Nationwide, Australia , Canada , France & The Netherlands
PRODUCT
a) AXIOM Artis System dFC using software version VB31D with 30x40
cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for single
and biplane diagnostic imaging and interventional procedures. Model number
7412807,
b) AXIOM Artis System dBA using software
version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography
system developed for single and biplane diagnostic imaging and interventional
procedures. Model number 7555357;
c) AXIOM
Artis System dFA using software version VB31D with 30x40 cm2 flat detectors.
ÿAXIOM Artis is a angiography system developed for single and biplane diagnostic
imaging and interventional procedures. Model number 7555373.
d) AXIOM Artis System dTC using software version VB31D with
30x40 cm2 flat detectors. ÿAXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures. Model
number 7413078;
e) AXIOM Artis System dTA
using software version VB31D with 30x40 cm2 flat detectors. ÿAXIOM Artis is a
angiography system developed for single and biplane diagnostic imaging and
interventional procedures. Model number 7008605;
f) AXIOM Artis System dMP using software version VB31D with 30x40 cm2
flat detectors. ÿAXIOM Artis is a angiography system developed for single and
biplane diagnostic imaging and interventional procedures; Model number 7555365;
CODE
a) Serial numbers: 35302,
35678, 35909, and 35916;
b) Serial numbers: 53086, 53128,
53149, 53162, 53165, and 53194;
c) Serial numbers: 50176
and 51707;
d) Serial numbers: 55090, 55322, and 55469;
e) Serial numbers: 57076, 57187, and 57188
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Siemens Medical Solutions USA, Inc., Malvern , PA ,
Manufacturer: Siemens AG, Medical Solution, Forchheim , Germany .
REASON
System may
switch to emergency fluoroscopy mode.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION Nationwide
PRODUCT AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A
Mindray Global Company. The AS3000 is a device used to administer to a patient,
continuously or intermittently, a general inhalation anesthetic and to maintain
a patient's ventilation;
CODE Serial Numbers: AN0804-001 and AN0804-006. Each AS3000 Anethesia
Delivery System is labeled with a unique serial number
RECALLING
FIRM/MANUFACTURER Mindray DS USA, Inc., dba Datascope Patient
Monitoring, Mahwah , NJ ,
REASON Two issues have been identified with
the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been
utilized, which may allow the caster to loosen and possibly separate from the
unit. 2. The use of select brands of pre-pack absorber in the absorber canister
of the AS3000 has been associated, in some cases, with gas leakage around the
pre-pack, rather than through the absorber material.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT syngo MultiModality WorkPlace (MM WP).
Software product (Model Number 10140720). The product is intended for use in
picture archiving and communications system;
CODE
Serial numbers: 7826, 7951, 7981, 7989, 8011,
8056, 8109, 8161, 8209, 8312, 8213, 8341, 8361, 8393, 8405, 8409, 8413, 8430,
8433, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8773,
8774, 8781, 8793, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081,
9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9243, 9244,
9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413,
9414, 9416, 9417, 9429, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536,
and 9568
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Siemens Medical Solutions USA, Inc., Malvern , PA , .
Manufacturer: Siemens Medical Solutions Inc., Erlangen , Germany .
REASON
Values derived
from Dynamic CT data sets may be incorrect. The corresponding images are not
affected.
VOLUME OF PRODUCT IN COMMERCE 84 units
DISTRIBUTION Nationwide
PRODUCT
a) Terumo Sarns Sternal Saw II System Power Unit, 115 V; Catalog #
15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system
consists of a disposable blade, saw, flexible drive shaft, motor and foot
control;
b) Terumo Sarns Sternal Saw II System
Power Unit, 220/240 V; Catalog # 7084. Note: This product was not sold in the
U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system
consists of a disposable blade, saw, flexible drive shaft, motor and foot
control; CODE
a) Serial numbers
5866 through 5887;
b) Serial numbers 1877 through 1925
RECALLING
FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor ,
MI
REASON The drive power cable cannot be fully inserted
into the power unit or can only be inserted with difficulty, resulting in the
device not being operational.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION Nationwide, Belgium
, China , Columbia , Malaysia , Philippines , United Arab Emirates , and
Venezuela
PRODUCT
a) 5 F BardSelect 11 cm Percutaneous
Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets,
including sheath, dilator, guide wire and needle, are used to facilitate placing
a catheter through the skin into a vein or artery. Percutaneous introducers are
recommended for initial percutaneous introduction or the exchange of
intravascular devices. Guide wire introducer needles are used for percutaneous
puncture and insertion into the blood vessel. The guide wire is then inserted
through the cannula of the introducer needle at the puncture site. The cannula
is then removed to allow insertion of the percutaneous catheter introducer
following removal of the guide wire introducer needle,
b) 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle,
c) 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle;
d) Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter
introducer sets, including sheath, dilator, guide wire and needle, are used to
facilitate placing a catheter through the skin into a vein or artery.
Percutaneous introducers are recommended for initial percutaneous introduction
or the exchange of intravascular devices. Guide wire introducer needles are used
for percutaneous puncture and insertion into the blood vessel. The guide wire is
then inserted through the cannula of the introducer needle at the puncture site.
The cannula is then removed to allow insertion of the percutaneous catheter
introducer following removal of the guide wire introducer needle,
CODE
a) Lot Number: 20111256;
b) Lot
Number: 20105869 and 20111254;
c) Lot Number: 21111255;
d) Lot Number:
20105895
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic, Inc, Danvers , MA ,
Manufacturer:
Thomas Medical Products, Inc., Malvern , PA.
REASON Failure to insert the guidewire through the 18
gauge introducer needle.
VOLUME OF PRODUCT IN COMMERCE 6,555 units
DISTRIBUTION
Nationwide,
Belgium , Honduras , and Germany
PRODUCT GE Healthcare Centricity Perinatal
(formerly Quantitative Sentinel) System - Alert and Reminder software; automatic
patient data management providing clinical information at the bedside in Labor
& Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare
Integrated IT Solutions, Barrington, IL 60010 Intended for use as a clinical
data management system;
CODE S oftware version 6.80.0 only with Alert and
Reminder feature activated
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington , IL
REASON
Software anomalies in the Alert and Reminder feature could result
in a delay of treatment. When attempting to select the last visible alert or
reminder choice, the next choice on the list below the desired choice is
selected, and an inconsistent color may be displayed for the same clinical
element across a set of work stations.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION OH
PRODUCT Calibration 1 Solution for the ABL700 series. P/N S1720, 944-024
Intended for in vitro testing of samples of whole blood for the parameters pH,
pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total
bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and
the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for
in vitro testing of samples of expired air for the parameters pO2 and pCO2. P/N
S1720, 944-024;
CODE Lot : WA-04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake , OH ,
Manufacturer: Radiometer Medical
ApS, Bronshoj ,
Denmark .
REASON For
this particular lot the barcode, used for entering the characteristics of CAL1
Solution into the analyzer, does not reflect the actual values of the solution.
As a consequence, the calibration curves for these parameters and thereby the
measured results for patient samples and quality controls will be biased.
VOLUME OF PRODUCT IN COMMERCE
3,200/200 ml bottles
DISTRIBUTION Nationwide and Canada
PRODUCT STERRAD NX Sterilizer, Product Code 10033 Low temperature
sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms
on a broad range of medical and surgical instruments;
CODE
Serial Numbers: 0033081006, 0033081007,
0033081016, 0033081017, 0033081019, 0033081020, 0033081022- 0033081029,
0033081036, 0033081039, 0033081048, 0033081059, 0033081080, 0033081082,
0033081086, 0033081088, 0033081089, 0033081091, 0033081095, 10033060892,
10033060379, 100330050671, 10033070576,10033080067,10033050663, and 10033050661
RECALLING FIRM/MANUFACTURER Advanced Sterilization
Products, Irvine , CA
REASON ASP has discovered a component
defect in some of the UV lamp power supplies used in certain STERRAD NX
Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to
give inaccurate readings.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION Nationwide, Ecuador
, China , Israel , Japan , Korea , Middle East , Australia , Czech Republic ,
Spain , Brazil , and Russia
PRODUCT Toddler Chair Hip Strap (Belt). The
hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical
Device Listing # R061877. The product is used as a hip strap chair for children,
CODE
Serial Numbers:
E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC,
E78020080703AD, E77020080701AD, E77020080701AA, E77020080701AB, E76020080704AA,
E78020080704AA, E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC,
E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA,
E76020080709AA, E78020080709AB, E77020080709AA, E77020080709AB, E77020080709AC,
E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE,
E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA,
E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF,
E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB,
E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB,
E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE,
E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC, E78020080719AA,
E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA,
E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC,
E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE,
E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA,
E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC,
E78020080725AA, E77020080725AA, E77020080725AB, E78020080728AB, E77020080728AA,
E78020080728AA, E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB,
E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB,
E77020080802AB, E77020080802AC, E78020080801AC, E77020080801AF, E77020080801AA,
E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC,
E77020080801AD, E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC,
E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA,
E77020080731AA, E77020080802AA, E77020080809AA, E77020080809AB, E78020080806AF,
E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA,
E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB,
E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB,
E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE,
E78020080812AG and E78020080812AH. The code is located underneath the seat of
the chair
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Community Products, LLC, Rifton , NY ,
Manufacturer : Community Products,
LLC,
Elka Park , NY .
REASON Some hip straps were assembled incorrectly by threading the buckle
on the strap upside down. If a child were left unattended in spite of the
warnings on the product and in the manual, a defective hip strap could loosen,
allowing the child to slip down in the chair and this could create a choking
hazard.
VOLUME OF PRODUCT IN COMMERCE
Potentially 147
units
DISTRIBUTION Nationwide, Spain and Great Britain
PRODUCT
a) PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with
Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x
23cm. NOTE: Both the "sport pack" and "kit" package configurations include the
catheter, Venetrac insertion stylets, pull apart sheath, and other accessories
necessary for placement. The Venetrac insertion stylet is an optional accessory.
The 510k for the Venetrac accessory is K051584. The 510k for the catheter is
K060509,
b) PALINDROME EMERALD SPORT PACK Cuffed
Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461,
Size 14.5Fr/Ch (4.85mm) x 28cm. NOTE: Both the "sport pack" and "kit" package
configurations include the catheter, Venetrac insertion stylets, pull apart
sheath, and other accessories necessary for placement. The Venetrac insertion
stylet is an optional accessory. The 510k for the Venetrac accessory is K051584.
The 510k for the catheter is K060509;
c)
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and
Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. NOTE: Both the
"sport pack" and "kit" package configurations include the catheter, Venetrac
insertion stylets, pull apart sheath, and other accessories necessary for
placement. The kit includes additional components that would also be available
at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion
stylet is an optional accessory. The 510k for the Venetrac accessory is K051584.
The 510k for the catheter is K060509,
d) PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter
with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x
28 cm. NOTE: Both the "sport pack" and "kit" package configurations include the
catheter, Venetrac insertion stylets, pull apart sheath, and other accessories
necessary for placement. The kit includes additional components that would also
be available at the hospital, such as a scalpel, wound dressing, etc. The
Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac
accessory is K051584. The 510k for the catheter is K060509,
CODE
a) Lot No: 809403 and 811762;
b) Lot No.
809405;
c) Lot No: 809404 and 811763;
d) Lot No. 809406 and 818002
RECALLING FIRM/MANUFACTURER Covidien, Argyle, NY,
REASON Incorrect size of the Venetrac stylets (an
optional accessory). They are too short and cannot be used.
VOLUME
OF PRODUCT IN COMMERCE 117 units
DISTRIBUTION Nationwide
WEEK ENDING DECEMBER 20
Recall of Two Unapproved Devices
A recall of two unapproved and uncleared devices was issued because manufacturers claimed these devices could treat various medical conditions.
The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. Because of original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.
Vibrational Integrated Bio-photonic Energizer device
VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.
HLX8 device
Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.
Nebion's first recall letter did not address the potential risks associated with the HLX8 device.
Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.
PRODUCT AMO Healon D Ophthalmic Viscosurgical
Device, Product Code: 10204011, 30 mg/mL fill size, CODE Lot Number: UD30654
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc.,
Santa Ana , CA ,
Manufacturer: Pharmacia
Diagnostics AB, Uppsala , Sweden .
REASON Endotoxin levels above specifications have been
noted in some syringes tested for lot number UD30654 of the AMO Healon D
Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level
may be potential causes of an inflammatory response and/or TASS in patients
following surgery.
VOLUME OF PRODUCT IN COMMERCE 1450
units
DISTRIBUTION Nationwide and PR
PRODUCT Gravity Compensating Accessory; High Pressure Range , Sterile,
Single Use, Rx only. CSF shunt accessory. The GCA is an implantable device
designed to be used in conjunction with implanted systems which. shunt
cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage
site a) Catalog number: 903-430, b) Catalog Number 903-435, c) Catalog Number
903-440,
CODE a) Lot Numbers
148792, 149247; b) Lot Numbers 147796, 148790; and c) Lot Numbers 147795, 149246
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra
LifeSciences Corp., Plainsboro , NJ ,
Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France.
REASON
Product has
the potential for CSF leakage under certain conditions.
VOLUME OF
PRODUCT IN COMMERCE 49 units
DISTRIBUTION Nationwide, Carnegie , Victoria , Melbourne , Australia
PRODUCT Terumo Sarns Level Sensor II Pads. For
use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion
System 900. REF 195240. Level Sensor pads are used to attach the level sensor to
the sides of a rigid reservoir,
CODE Lot Number 78925
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor , MI
REASON The level sensor holder may detach from the adhesive pad causing
the sensor to lose contact with the venous reservoir, which may result in a
detached sensor indication or false alarm.
VOLUME OF PRODUCT IN
COMMERCE 31,980 units
DISTRIBUTION Nationwide, Australia , Belgium , Canada , China , Dominican
Republic , Japan , Saudi Arabia , Singapore and Yemen
PRODUCT
a) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump;
Model 801040). Extracorporeal circulation of blood for arterial perfusion,
regional perfusion, and cardiopulmonary bypass procedures,
b) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures,
c) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures,
d) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump,
Gray; Model 816571). Extracorporeal circulation of blood for arterial perfusion,
regional perfusion, and cardiopulmonary bypass procedures,
CODE
a) Serial numbers 0028 through 0111, 0113 through
0527, 0700 through 1528, 1539 through 1579, 2000 through 2392 and 2395 through
2466;
b) Serial numbers 0030, 0032 through 0587, 0700 through
1936, 1947 through 1951 and 2000 through 2799;
c) Serial numbers
1001 through 1008 and 4009 through 4269;
d) Serial numbers 1001
through 1008 and 4009 through 4414
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor , MI ,
REASON
Overspeed and underspeed errors, erratic pump behavior, jerky
operation at low RPMs, pump instability, pump slowdowns and pump stops due to
overspeed max events may occur due to a grease leak onto the motor speed encoder
disk.
VOLUME OF PRODUCT IN COMMERCE
5116 units
DISTRIBUTION Nationwide, Australia , Belgium . Canada,
Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India,
Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan,
Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan,
Thailand, Turkey, United Arab Emirates and Viet Nam
PRODUCT
a) Mentor Aseptic Transfer Set, Cat.
b) contains BD 60mL
Luer-Lok Syringe, Reorder Number: 309653
CODE
a) All lots.
b) Lot numbers beginning with the numbers 5, 6, or
7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117,
8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896,
8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and
8079656
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Mentor Texas, Inc., Irving , TX ,
Manufacturer: Becton Dickinson & Company, Franklin Lakes , NJ.
REASON
The Mentor Aseptic
Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under
recall by Becton Dickinson due to a package integrity issue.
VOLUME
OF PRODUCT IN COMMERCE 32,480 sets
DISTRIBUTION Nationwide (except Alaska ), PR, Australia , Canada , Costa Rica ,
Korea , New Zealand and South Africa
PRODUCT Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.
Intended Use: The dual heated adult respiratory ventilator circuits are intended
as conduits of breathing gas for ventilation of patients, and to maintain the
temperature of the humidified gas, to reduce condensation,
CODE All lot numbers up to and including Lot 080627
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fisher
& Paykel Healthcare Inc., Huntington Beach , CA ,
Manufacturer: Fisher & Paykel Electronics, Ltd, Auckland , New
Zealand .
REASON The
recall was initiated because certain lot dates of the RT240 Adult Breathing
Circuit Kits manufactured on or before June 27, 2008 include a heated breathing
circuit that may be more susceptible to damage when used in excess of the
specified seven-day maximum duration of use, which may increase the risk of
malfunction or fire.
VOLUME OF PRODUCT IN COMMERCE
229,320 units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Dual Port Wizard Low Profile
Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO. Dual
Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile
balloon-type device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a
kit which also includes two tubes, two gauze pads, and a syringe. The Wizard
anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The
inserted device is used for enteral feeding,
b)
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F,
1.7cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy
Device is a silicone low-profile balloon-type device designed for percutaneous
insertion through an established, appropriately sized stoma tract. The Dual Port
Wizard Device is packaged in a kit which also includes two tubes, two gauze
pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual
Port Wizard Gastrostomy Device. The inserted device is used for internal
feeding,
c) Dual Port Wizard Low Profile
Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile EO. Dual
Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile
balloon-type device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a
kit which also includes two tubes, two gauze pads, and a syringe. The Wizard
anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The
inserted device is used for enteral feeding,
d)
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F,
1.2cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy
Device is a silicone low-profile balloon-type device designed for percutaneous
insertion through an established, appropriately sized stoma tract. The Dual Port
Wizard Device is packaged in a kit which also includes two tubes, two gauze
pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual
Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding,
e) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO,
f) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00205W, 20F, 2.4cm, 10cc, Sterile EO,
g) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00206W, 20F, 3.4cm, 10cc, Sterile EO,
h) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00207W, 20F, 4.4cm, 10cc, Sterile EO,
i) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc, Sterile EO,
j) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00210W, 16F, 2.4cm, 20cc, Sterile EO,
k) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00212W, 20F, 1.7cm, 20cc, Sterile EO,
l) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00213W, 20F, 2.4cm, 20cc, Sterile EO,
m) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00214W, 20F, 3.4cm, 20cc, Sterile EO, Recall #
Z-0428-2009;
n) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00215W, 20F, 4.4cm, 20cc, Sterile EO,
o) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc, Sterile EO,
p) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00217W, 24F, 2.4cm, 20cc, Sterile EO,
q) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00218W, 24F, 3.4cm, 20cc, Sterile EO,
r) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00219W, 24F, 4.4cm, 20cc, Sterile EO,
s) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00221W, 18F, 1.2cm, 10cc, Sterile EO,
t) Dual Port Wizard Low Profile Replacement
Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc, Sterile EO,
u) Dual Port Wizard Low Profile Replacement Gastrostomy
Device, Code 00223W, 18F, 2.4cm, 10cc, Sterile EO,
v) Dual Port Wizard Low Profile Replacement Gastrostomy Device,
Code 00224W, 18F, 3.4cm, 10cc, Sterile EO,
w) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W,
18F, 4.4cm, 10cc, Sterile EO,
CODE
a) 43AOA018, 43AOA041, 43APA032, 43BOA015, 43BOA037, 43BPA025,
43BQA042, 43BQA184, 43COA013, 43COA036, 43CQA232, 43DOA010, 43DOA037, 43DPAO14,
43DQA063, 43EOA0 13, 43EOA041, 43EPAO13, 43EPA040, 43FOA076, 43FOA107, 43FOA234,
43GOA033, 43GOA009, 43GPA177R, 43GPA178R, 43GPA190R, 43GPA195R, 43HOA031,
43HPA018, 43HPA050, 43HPA223R, 43INA031, 43IOA038, 43IPA017R, 43IPA207R,
43IQA001, 43JNAOO1, 43JNAO44, 43JNA203, 43JNA219, 43JOA014, 43JPA013, 43JPA036,
43KNA012, 43KNA053, 43KOA016, 43KPA013, 43LNAO22, 43LNAO52, 43LOA023, 43LQA001,
HURB2525, HURB3526, HURD1915, HURF0483, HURG1443, HURH1078, HURJ0571, HURB2422,
HURD0734, HURE0535, HURE2889, HURG1444, and HURJ0594;
b)
43AOA019, 43LNA053, 43AOA042, 43LOA024, 43APA033, 43LPA008, 43ARAOO2, 43LQAO29,
HURA1265, 43BOA016, HURB2526, 43BOA038, HURB4356, 43BQA043, HURB4357, 43COA014,
HURD1917, 43COA037, HURF0484, 43DOA011, HURG1445, HURH1079, HURJ0002, 43DOA038,
43DOA203, 43DPA015, HURJ0595, 43DPA044, HURJ1549, 43DPA204, HURK1491, 43DPA205,
HURB2425, 43DQA064, HURB4421, 43EOA014, HURD1916, 43EOA042, HURE2890, 43EPA014,
HURF0485, 43EPAO41, HURH0242, 43EPA209, HURH1080, 43EPA216, HURJ1557, 43EQA009,
43FOA077, 43FOA108, 43GOA034, 43GPA179R, 43GPA180R, 43GQA001, 43GQA032,
43HPA019R, 43HPA192, 43HPA225R, 43HQA001, 43HQA165, 43INA032, 43IOA039,
43IPAO18, 43IPA041, 43IPA199R, 43IQA002, 43JNA002, 43JNA045, 43JNA204, 43JOA015,
43JPA014, 43JPA037, 43JQA001, 43JQA027, 43KPA014, 43KQA001, 43KQA027, and
43LNA023;
c) 43AOA020, 43AOA012, 43APA014, 43JQA028, 43APA034,
43KNA054, 43KPA015, 43ARA030, 43KQA028, 43BOA017, 43LNA024, 43BPA010, 43LNA054,
43BQA007, 43LOA009, 43BQA044, 43LOA025, 43COA015, 43LPA112, 43CPA014, 43LQA003,
43CQA015, 43LQA030, 43CQA234, HURA1274, HURB2527, 43DOA012, HURB4359, 43DPA016,
HURB4563, 43DPA045, HURD1919, 43DPA206, HURE2891, 43DQA009, HURF0487, 43EOA015,
HURG1446, 43EOA043, HURH1082, 43EPAO15, HURJ0005, 43EPA042, 43EPA217, HURJ0597,
43EQA010, HURCA095, 43FOA078, HURE2892, 43FOA109, HURF0486, 43FOA229, HURG1447,
43FQA001, HURH1081, 43GOA011, HURJ0598, 43GPA147, HURJ1559, 43GPA148, 43GPA196R,
43GPA230R, 43GPA231R, 43GQA002, 43GQA033, 43HOA033, 43HPA020, 43HPA051,
43HQA002, 43HQA155, 43HQA163, 43IOA013, 43IOA040, 43IPA019, 43IPA212, 43IPA213,
43IQA003, 43JNA003, 43JOA016, 43JPA015, 43JPA193, and 43JQA002;
d) 43AOA043, 43BOA018, 43BQA045, 43BQA156, 43COA016, 43COA038, 43CQA016,
43CQA235, 43DOA013, 43DPA017, 43DPA207, 43DQA010, 43DQA065, 43EOA016, 43EOA044,
43EPA016, 43EPA043, 43EQA011, 43EQA182, 43FOA110, 43FOA230, 43GPA184R,
43GPA185R, 43GPA186R, 43GPA187R, 43GPA220R, 43GPA221R, 43GQA034, 43HPA052R,
43HQA003, 43lNA034, 43IOA014, 43IPA020, 43JOA017, 43JPA016, 43KQA029, 43LOA026,
43LQA004, 43LQA031, HURB2529, HURD0665, HURD1920, HURJ0599, HURK1509, HURB2427,
HURE2894, HURH1083,and HURJ0600;
e) 43APA035, 43ARA005, 43BOA039,
43BQA008, 43BQA046, 43COA017, 43COA039, 43CQA017, 43CQA236, 43DOA014, 43DPA208,
43DPA209, 43DQA011, 43EOA017, 43EOA045, 43EPA017, 43EPA044, 43EPA210, 43FOA080,
43FOA111, 43FQA002, 43GPA174R, 43GPA175R, 43GPA192R, 43GQA003, 43HOA034,
43HPA021R, 43HPA053R, 43HQA004, 43INA014, 43IOA041, 43IPA021R, 43IPA043R,
43IQA004, 43JNA004, 43JNAO47, 43JNA206, 43JOA018, 43JPA017, 43JPA038, 43JQA003,
43KNA015, 43KOA017, 43KPA016, 43KPA056, 43KQA003, 43KQA030, 43LNA055, 43LOA027,
43LPA009, 43LPA039, 43LQA005, 43LQA032, HURB3524, HURB4420, HURD1921, HURG1448,
HURH1084, HURJ0602, HURK1510, HURB2428, HURD0505, HURE2896, and HURJ0601;
f) 43AOA021, 43AOA044, 43APA036, 43ARA284, 43BOA020, 43BOA021, 43BPA011,
43BPA026, 43BQA047, 43BQA185, 43CPA016, 43CPA196, 43CQA018, 43CQA019, 43CQA020,
43DPA018, 43DPA019, 43DPA046, 43DPA210, 43DQA012, 43DQA066, 43EOA018, 43EOA019,
43EPA018, 43EPA045, 43EPA211, 43EPA214, 43EQA012, 43EQA013, 43EQA051, 43EQA206,
43FOA081, 43FOA082, 43FOA083, 43FOA084, 43FOA085, 43FOA112, 43FOA233, 43FQA039,
43GOA014, 43GOA015, 43GPA197R, 43GPA237R, 43GQA004, 43HPA022, 43HPA023,
43HPA054, 43HQA005, 43HQA006, 43HQA031, 43HQA156, 43INA015, 43INA036, 43IOA016,
43IOA017, 43IOA042, 43IPA022, 43IPA044, 43IPA208R, 43IQA005, 43IQA029, 43JNA005,
43JPA018, 43JPA019, 43JPA039, 43JQA004, 43KNA016, 43KNA055, 43KOA011, 43KOA018,
43KPA017, 43KQA004, 43KQA031, 43LNA025, 43LOA028, 43LQA006, 43LQA033, HURA1293,
HURB3527, HURD0567, HURD1924, HURD1925, HURE2898, HURE2899, HURE2900, HURF0491,
HURG0212, HURG1015, HURG1449, HURG1450, HURH1086, HURH1087, HURI0668, HURI0677,
HURJ0892, HURJ1573, HURK1261, HURB2429, HURB2430, HURCA647, HURD1922, HURE2901,
HURF0492, HURH1088, HURI0866, HURJ0603, and HURK1511;
g) 43A0A022,
43A0A023, 43APA037, 43ARA007, 43BOA022, 43BOA175, 43BPA012, 43BQA162, 43BQA163,
43BQA164, 43COA019, 43COA211, 43CPA017, 43CPA018, 43CQA02 I, 43CQA022, 43CQA023,
43DOA018, 43DPA020 43DPA02 I, 43DPA022, 43DPA211, 43 DPA212, 43DQA014, 43DQA015,
43DQA017, 43EPA019, 43EPA046, 43EPA212, 43EPA215, 43EPA227, 43EQA052, 43FOA086,
43FOA087, 43FOA088, 43GOA016, 43GOA017, 43GOA035, 43GPA149, 43GPA198R,
43GPA199R, 43GPA233R, 43GQA007, 43GQA008, 43GQA009, 43HPA024, 43HPA025,
43HQA007, 43HQA008, 43HQA158, 43 INA016, 43INA037, 43INA223, 43IOA018, 43IOA019,
43IOA020, 43IOA181, 43 IPA023, 43IPA024, 43IPA045R, 43IQA006, 43IQA007,
43IQA030, 43JOA019, 43JPA020, 43JPA040, 43JQA005, 43JQA006, 43JQA030, 43JQA151,
43JQA154, 43KNA017, 43KNA056, 43KOA012, 43KOA019, 43KPA018, 43KPA189, 43KQA005,
43KQA006, 43KQA032, 43LNA026, 43LNA056, 43LOA029, 43LPA010, 43LQA007, 43LQA034,
HURA1302, HURA1309, HURB2533, HURD0568, HURD1926, HURD1927, HURE2902, HURE2903,
HURE2904, HURF0493, HURF0494, HURF0495, HURG1451, FIURG1452, HURH0004, HURH1089,
HURH1090, HURI0669, HURI0678, HURJ1579, HURJ1582, HURK0006, HURK1262, HURK15I2,
HURL0023, HURA1315, HURC9665, HURCA105, HURJ1150, HURJ1577, and HURL0228;
h) 43APA015, 43APA038, 43ARA285, 43ARA290, 43BOA023, 43BPA013, 43COA020,
43CQA025, 43DOA022, 43DPA023, 43DPA047, 43DPA225, 43DQA018, 43EQA018, 43EQA053,
43EQA205, 43FOA090, 43FPA177, 43GOA018, 43GPA150, 43GPA200R, 43GQA011, 43GQA191,
43HOA017, 43HOA035, 43HPA026, 43HPA027, 43HQA009 43INA017, 43INA038, 43IOA021,
43I0A043, 43IPA025, 43IPA046, 43IPA200R, 43IQA008, 43IQA031, 43JNA006, 43JNA048,
43JOA004, 43JOA020, 43JPA021, 43JPA041, 43JQA007, 43KNA018 43KNA057, 43KOA020,
43KPA019, 43KQA033, 43LNA027, 43LOA010, 43LOA030, 43LOA008, HURA1321, HURB2536,
HURB4365, HURB4366, HURD0671, HURD0672, HURD1928, HURE2906, HURF0496, HURG1454,
HURH1091, HURJ0604, HURJ1586, HURK1513, and HURE2905;
i) 43BOA040,
43COA194, 43DOA040, 43DPA213, 43EOA046, 43EPA048, 43FOA114, 43GOA036, 43GPA222R,
43INA035, 43INA039, 43IOA044, 43JOA021, 43KNA058, 43KQA034, 43LOA031, 43LQA036,
HURB2537, HURD0674, HURF0498, and HURI0525;
j) 43APA039, 43DOA041,
43DOA202, 43DPA214, 43EOA047, 43EPA0049, 43FOA115, 43GPA209R, 43HPA055,
43HPA224R, 43INA040, 43IOA182, 43IPA047, 43JOA022, 43JPA042, 43KNA059, 43KOA021,
43KQA035, 43LOA032, 43LQA037, HURA1325, HURH0261, HURJ0606, and HURJ1589;
k) 43APA040, 43BPA028, 43DPA049, 43EPA050, 43EPA228, 43EQA055, 43FOA116,
43FQA041, 43GOA037, 43GPA211R, 43HOA036, 43HPA218, 43HPA226R, 43HQA032,
43INA041, 43I0A045, 43K0A022, 43KQA036, 43LOA033, 43LQA038, HURA1329, HURG1455,
HURH1092, HURJ0607, and HURJ1590;
l) 43APA041, 43BQA048 43bQA187,
43DOA201, 43DPA050, 43DPA215, 43DQA067, 43EOA048, 43FOA117, 43FPA178, 43FQA042,
43GPA151, 43GPA212R, 43GPA236R, 43GQA035, 43HOA037, 43HPA056, 43HQA033,
43IOA046, 43IPA048, 43IQA032, 43JNA049, 43JNA222, 43JOA023, 43JPA043, 43KPA058,
43KQA037, 43LNA057, 43LOA034, HURD0675, HURD1929, HURE2907, HURF0500, HURH1093,
HURJ0608, HURJ1591, and HURK1515;
m) 43APA042, 43COA041, 43DOA042,
43DOA200, 43DPA051, 43DQA068, 43EOA049, 43EPA052, 43FOA118, 43FPA179, 43FQA043,
43GOA038, 43GPA152, 43GPA213R, 43GPA238R, 43GQA036, 43HOA038, 43HPA057,
43HPA227R, 43HQA034, 43IOA047, 43IPA049, 43IQA033, 43JNA050, 43JNA223, 43JOA024,
43JPA044, 43KOA023, 43KOA161, 43KQA038, 43LNA058, 43LOA035, 43LQA040, HURA1337,
HURB2433, HURE2908, HURF0501, HURH1094, HURJ0609, HURJ1592, and HURL0235;
n) 43AOA045, 43BOA041, 43BPA031, 43BQA049, 43BQA188, 43DOA043, 43DPA052,
43DPA216, 43EOA050, 43EPA053, 43FOA119, 43GPA214R, 43HPA058, 43HPA228R,
43HQA035, 43INA044, 43IOA048, 43IPA050, 43JOA025, 43JPA045, 43KOA024, 43KPA059,
43KQA039, 43LOA036, 43LPA041, 43LQA041, HURA1339, HURC9895, HURG1456, HURH1095,
HURJ0610, and HURJ1593;
o) 43AOA025, 43BOA024, 43BOA042, 43BQA009,
43BQA050, 43COA021, 43COA042, 43CQA026, 43DOA023, 43DPA024, 43DPA217, 43DQA019,
43DQA069, 43EOA025, 43EPA022, 43EQA019, 43FOA091, 43FOA120, 43FPA180, 43FQA008,
43GOA019, 43GOA039, 43GPA153, 43GPA176R, 43GPA191R, 43GPA215R, 43GPA216R,
43GPA217R, 43GPA239R, 43GQA012, 43HOA040, 43HPA028, 43HPA059, 43HPA219,
43INA018, 43INA045, 43IOA049, 43IPA026, 43IPA051, 43IPA205R, 43IQA015, 43JOA026,
43JPA022, 43JPA046, 43JQA008, 43KNA019, 43KNA061, 43KOA025, 43KPA020, 43KQA008,
43LNA028, 43LNA059, 43LOA037, 43LPA011, 43LQA009, HURB2435, HURD0683, HURD1931,
HURE2909, HURH1096, HURJ0612, HURJ1595, HURK1516, HURA1341, HURD1930, HURG1457,
HURI0867, and HURJ0611;
p) 43AOA026, 43AOA046, 43ARA010, 43ARA286,
43ARA288, 43BOA025, 43BOA043, 43BPA014, 43BPA032, 43BQA051, 43BQA189, 43COA022,
43COA195, 43CQA233, 43DOA024, 43DOA044, 43DPA025, 43DPA218, 43DPA219, 43DQA020,
43DQA070, 43EPA023, 43EPA055, 43EPA213, 43EQA020, 43FOA092, 43FOA121, 43FOA228,
43FQA009, 43GOA020, 43GOA040, 43GPA154, 43GPA181R, 43GPA182R, 43GPA193R,
43GPA194R, 43GPA241R, 43GQA013, 43HOA019, 43HOA041, 43HPA029, 43HQA010,
43INA046, 43IOA050, 43IPA027, 43IPA052, 43IQA010, 43IQA034, 43JNA207, 43JOA027,
43JPA023, 43JPA047, 43JQA009, 43KNA020, 43KNA062, 43KPA021, 43KPA060, 43KQA040,
43LNA029, 43LOA038, 43LPA012, 43LPA013, 43LPA042, 43LPA111, 43LQA010, 43LQA042,
HURA1342, HURD0697, HURD1932, HURE2910, HURF0503, HURG1246, HURG1459, HURH1097,
HURI0680, HURJ1596, HURK1517, HURD0689, HURD1933, HURE3341, HURG1460, HURH1098,
HURJ0613, and HURJ1597;
q) 43AOA027, 43APA043, 43ARA011, 43ARA043,
43ARA289, 43BOA026, 43BPA015, 43BQA010, 43COA023, 43CPA022, 43CQA027, 43CQA237,
43DOA025, 43DOA045, 43DPA026, 43DPA220, 43DPA221, 43DQA021, 43DQA071, 43EPA056,
43EPA241, 43EQA021, 43EQA056, 43EQA207, 43FOA093, 43FOA122, 43FOA235, 43FQA010,
43GOA021, 43GOA041, 43GPA155, 43GPA156, 43GPA183R, 43GPA218R, 43GPA219R,
43GPA242R, 43GQA014, 43HPA030, 43HPA060, 43HPA237, 43HQA011, 43INA9020,
43INA047, 43IOA023, 43IPA028, 43IPA053, 43IQA011, 43JNA208, 43JOA028, 43JPA024,
43JPA048, 43JPA203, 43JQA010, 43 JQA031, 43KOA026, 43KPA022, 43KQA010, 43KQA041,
43LNA030, 43LNA060, 43LOA039, 43LQA011, HURA1343, HURD1934, HURE2214, HURE2911,
HURF0505, HURG1461, HURH1099, HURI0682, HURJ1599, HURK1291, HURA1344, HURCA110,
HURE3342, HURF0506, HURH0272, HURH1100, HURJ0614, and HURL0236;
r)
43LQA012, 43LPA015, 43LOA040, 43LOA011, 43KQA042, 43KQA011, 43KPA023, 43KOA027,
43KNA064, 43KNA022, 43JQA032, 43JQA011, 43JPA025, 43JOA029, 43JNA019, 43JNA007,
43IQA012, 43IPA029, 43IOA052, 43IOA024, 43lNA048, 43HQA012, 43HPA031, 43GQA015,
43GPA243R, 43GPA203R, 43GPA202R, 43GPA201R, 43FOA094, 43EQA057, 43EQA022,
43EPA057, 43EPA025, 43EOA028, 43DQA022, 43DPA224, 43DPA223, 43DOA046, 43CQA028,
43COA024, 43BQA190, 43BQA052, 43BQA011, 43BOA176, 43APA016, HURA1345, HURB3430,
HURD1935, HURE2912, HURF0507, HURG1462, HURH1101, HURJ0008, HURJ1600, HURK1518,
HURB2543, HURE3343, and HURJ0615;
s) 43APA017, 43APA044, 43DPA027,
43EPA026, 43EPA058, 43EPA221, 43EQA058, 43FOA124, 43GPA157, 43GPA223R,
43GPA245R, 43HPA032, 43HPA061, 43IPA054R, 43JNA051, 43JOA030, 43JPA049,
43KNA065, 43KOA028, 43KQA043, 43LQA045, HURA1346, HURD0570, HURE2915, HURH0005,
HURB2443, HURB2546, HURD0569, HURE0371, and HURJ0894;
t) 43APA018,
43BPA033, 43BQA053, 43CPA025, 43DPA028, 43DPA053, 43FPA181, 43GPA158, 43GPA159,
43HPA062, 43HPA233R, 43HQA036, 43INA049, 43IOA053, 43JNA052, 43JOA031, 43JPA050,
43KNA066, 43KOA029, 43KPA061, 43KQA044, 43LOA041, 43LPA043, 43LQA046,
HURA1348,HURE3351, HURF0511, and HURJ0895;
u) 43APA019, 43APA045,
43BPA193, 43BQA054, 43BQA191, 43COA043, 43CPA026, 43CPA027, 43DOA047, 43EPA028,
43EPA060, 43FOA125, 43FQA044, 43GOA042, 43GPA160, 43GPA161, 43GQA037, 43HPA063,
43HQA037, 43IOA183, 43IQA035, 43IQA175, 43JNA053, 43JOA032, 43JPA051, 43KNA067,
43KOA030, 43KQA045, 43LNA062, 43LOA042, 43LQA047, HURH0006, HURI0364, HURJ0259,
HURJ1608, HURK1519, HURB2547, HURE2916, HURG1467, HURH0714, HURJ0896, HURJ1607,
HURJ1609, and HURK1520;
v) 43APA020, 43APA046, 43APA193, 43BPA188,
43BQA055, 43CPA028, 43CPA029, 43DPA030, 43EOA193, 43EPA029, 43EPA223, 43FOA126,
43FPA182, 43GPA162, 43GPA163, 43GQA175, 43HPA064, 43INA051, 43IQA036, 43JOA033,
43JPA052, 43JQA033, 43KOA031, 43KPA062, 43KQA046, 43LNA063, 43LOA043, 43LPA044,
43LQA048, HURE2918, HURF0513, HURG1468, HURH1498, HURI0681, HURJ0898, HURA1350,
HURCA120HURE2917, HURF0176HURH1109, HURJ0899, and HURK1521
w) 43AOA047,
43APA021, 43BPA206, 43COA044, 43CPA030, 43DPA031, 43FOA127, 43GPA183, 43GPA164,
43GPA165, 43GPA207R, 43GPA208R, 43HPA038, 43HPA065, 43HPA229R, 43IOA184,
43JOA034, 43KNA069, 43KOA032, 43LNA064, 43LQA049, HURE2919, HURG1469, HURH1110,
HURJ0900, and HURK1522
RECALLING FIRM/MANUFACTURER
Recalling Firm: C R Bard Inc., Salt Lake City , UT , Manufacturer:
Bard Puerto Rico, Humacao, Puerto Rico .
REASON Gastrostomy
device anti-reflux valve may allow leakage from the stomach.
VOLUME
OF PRODUCT IN COMMERCE
21,079 units
DISTRIBUTION
Nationwide, Latin America, Canada, Japan, Finland, Norway, Sweden,
Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain,
Germany
PRODUCT Modular Shoulder Body Assembly, 15mm,
Left (SH-1540L-S) and Modular Shoulder Body Assembly, 15mm, Right (SH-1540R-S).
Product labeled in part,
CODE
Lot
: W51097 (W=work order, ###=sequential number); Expiration date: 2012-06
(Year/Month); Modular Shoulder Body Assembly, 15mm, Right : Part number:
SH-1540R-S ; Work order number/Lot: W51098 (W=work order, ###=sequential
number); Expiration date: 2012-06 (Year/Month).
RECALLING
FIRM/MANUFACTURER Acumed LLC, Hillsboro , OR ,
REASON
The packages for Modular Shoulder Body Assembly Left (SH-1540L-S)
and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for
the opposite side as indicated.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION Nationwide, UK ,
South Korea , South Africa , and Spain
PRODUCT GE Centricity PACS RA1000 Workstation
(for diagnostic image analysis). The Centricity" PACS Workstation is intended
for use as a primary diagnostic and analysis tool for diagnostic images by
trained healthcare professionals. It is also intended for use as a clinical
review workstation throughout the healthcare facility. The workstation interface
provides the user with a means to display, manipulate, archive, print, and
export images when connected with the Centricity" PACS infrastructure,
CODE
1) Software version 2.1.X (from
2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases
prior to 2.1.5.1 for the default display protocol issue), and 2) Software
version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue
and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT
Solutions, Barrington , IL , by letter dated September 25, 2008. Firm initiated
recall is ongoing.
REASON Software anomalies result in
patient safety issues involving patient jacket content intermittently becoming
unintentionally out of synchronization with the images being displayed, and
involving Default Display Protocols (DDPs) which are used to layout images when
displaying a study. If the user does not check the Study Date Time of the exam
on the image title bar, then they may interpret the current exam as a historical
study and vice versa.
VOLUME OF PRODUCT IN COMMERCE
546
units
DISTRIBUTION Nationwide, Australia, Belgium,
Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong
Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore,
Spain, Switzerland, Taiwan, United Kingdom and Venezuela
PRODUCT RNAgents® Total RNA Isolation System (Cat. # Z5110). Kit Box
label/Box drawer label. For Laboratory Use. Bottle Label: Phenol: Chloroform:
Isoamyl Alcohol (Cat. # Z5112). Part Two of Two of Z5110. Size 100ml. For
laboratory Use. A component of the RNAgents® Total RNA Isolation System. The
RNAgents® Total RNA Isolation System provides a scalable method for RNA
isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The
system reduces the level of chromosomal DNA, a major advantage when the
downstream application of amplification and analysis of RNA transcripts is
desired. Isolated RNA can be resuspended in any volume, making the system ideal
for microarrays,
CODE Lot Codes:
237809 and 248195
RECALLING FIRM/MANUFACTURER Promega
Corporation, Madison , WI ,
REASON Reports
of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol, Promega product Z5112
is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin,
it can cause burns and poisoning. The fumes of this product are also harmful.
VOLUME OF PRODUCT IN COMMERCE
836 units
DISTRIBUTION Nationwide, Canada ,
Mexico , Brasil , China , Japan , Germany , Singapore , Great Britain ,
Australia and France .
PRODUCT Dimension Enzymatic Creatinine Flex
reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the
quantitative measurement of creatinine in human serum, plasma, and urine on the
clinical chemistry system. Creatinine measurements are used in the diagnosis and
treatment of renal diseases, in monitoring renal dialysis, and as a calculation
basis for other urine analyses,
CODE Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062,
GA9043, GD9069, and GD9087
RECALLING FIRM/MANUFACTURER Dade
Behring, Inc., Newark , DE
REASON Reagent may exhibit unflagged inaccurate patient sample results.
VOLUME OF PRODUCT IN COMMERCE 12,773 cartons
DISTRIBUTION Nationwide
Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades
Product:
Greenline/D MacIntosh No. 3 Laryngoscope Blades, Sterile and Disposable, Contents 20/box.
This recall only involves lot codes Gj and Ha.
This device was manufactured from July, 2006 through March, 2007 and distributed from January 16, 2007 through April 13, 2007.
Use:
The blades are part of a medical device (laryngoscope) used to view the vocal cords and other structures when opening a patient’s airway.
Recalling Firm:
Sun Med
12393 Belcher Road, Suite 450
Largo, Florida 33773-3097
Reason for Recall:
A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure.
Public Contact:
The company may be contacted at 1-727-530-7099.
WEEK ENDING DECEMBER 27
PRODUCT Boston Scientific iLab Ultrasound
Imaging System, models 120INS and 240INS. Its intended use is for ultrasound
examination of intravascular pathology, CODE
ILAB120CART: UPN: H749ILAB120CARTD0 Serial #s: 4033 4058 4063 4098
4171 ACQUISITION PC: UPN: H749ILACQPCFRU010 H749ILACQPCFRU01D0
H749ILACQPCFRU01H0 H749ILACQPCFRU01R0 H749ILACQPCFRU01Z0 H749ILACQPCFRU020
H749ILACQPCFRU02D0 H749ILACQPCFRU02H0 H749ILACQPCFRU02R0 H749ILACQPCFRU02Z0
H749ILACQPCFRU030 H749ILACQPCFRU03H0 H749ILACQPCFRU03R0 H749ILACQPCFRU03Z0
H749ILACQPCFRU040 H749ILACQPCFRU04R0 H749ILACQPCFRU04Z0 H749ILACQPCFRU050
H749ILACQPCFRU05R0 H749ILACQPCFRU05Z0 H749ILACQPCFRU060 H749ILACQPCFRU06R0 and
H749ILACQPCFRU06Z0 Serial #s: 1580359 1611146 L10076 L10227 L10442 L10714.
1580642 1611147 L10081 L10233 L10443 L10717 1581015 1611152 L10083 L10239 L10444
L10739 1581022 1611153 L10086 L10243 L10456 L10761 1581024 1611192 L10093 L10255
L10464 L10766 1582415 1611195 L10095 L10257 L10471 L10774 1582418 1611200 L10099
L10269 L10511 L10776 1582871 1611416 L10109 L10284 L10531 L10782 1582881 1611422
L10113 L10292 L10541 L10785 1583625 1611423 L10115 L10309 L10543 L10807 1583628
1611424 L10120 L10311 L10555 L10809 1583629 1611429 L10122 L10314 L10556 L10838
1583634 1611430 L10125 L10318 L10562 L10840 1583635 1611434 L10129 L10320 L10565
L10855 1583636 1611702 L10130 L10332 L10579 L10863 1583637 16081315 L10131
L10336 L10582 L10867 1583638 L10000 L10132 L10345 L10588 L10873 1583641 L10002
L10139 L10357 L10589 L10878 1583643 L10006 L10162 L10362 L10593 L10900 1588611
L10010 L10164 L10365 L10597 L10909 1590153 L10016 L10166 L10369 L10603 L10920
1607244 L10018 L10168 L10371 L10611 L10946 1607292 L10021 L10169 L10375 L10617
L10953 1607482 L10024 L10170 L10377 L10619 L10963 1607721 L10026 L10177 L10382
L10620 L10970 1607723 L10028 L10178 L10399 L10624 L10981 1608316 L10033 L10179
L10407 L10627 L10991 1609451 L10055 L10180 L10419 L10632 L10999 1609454 L10057
L10186 L10422 L10648 L11022 1611078 L10070 L10188 L10430 L10665 L11035 1611080
L10071 L10195 L10434 L10679 L11036 1611081 L10072 L10196 L10436 L10680 L11040
1611085 L10074 L10198 L10439 L10691 L11052 1611144 L10075 L10207 L10440 L10710
L11060 and Model UPN Serial # IMAGE PROCESSOR H749ILIMGPCFRU010
H749ILIMGPCFRU01D0 H749ILIMGPCFRU01H0 H749ILIMGPCFRU01R0 H749ILIMGPCFRU01Z0
H749ILIMGPCFRU020 H749ILIMGPCFRU02R0 H749ILIMGPCFRU02Z0 H749ILIMGPCFRU030
H749ILIMGPCFRU03R0 and H749ILIMGPCFRU03Z0 296968 313715 321630 322849 336162
340786. 297060 313717 321631 322861 336163 340792 297061 313720 321632 327138
336253 340805 297062 314198 316790 327148 336256 340809 297063 314203 316792
327150 336257 341460 300862 314218 316801 329820 336269 342235 300865 314223
316802 329823 336343 342237 300866 315336 316803 329825 336344 342243 300868
315340 321641 329836 336349 342752 300876 315343 321642 329844 336718 342773
302076 315344 321647 329867 336720 806347299 302079 315426 321650 331555 336727
806347312 303104 315427 321651 331556 336734 806347323 303108 315434 323025
331564 336735 806347324 304636 315708 323029 331582 336795 806347327 304637
315709 323037 331590 336807 807348245 304640 315710 323039 332318 337432
807348248 305670 315714 323058 332319 337456 807348253 305675 315716 324211
332328 337480 807348257 306636 315720 324221 332339 338772 807348259 306637
315721 324225 332348 338777 807348268 306640 315723 324236 332349 338789
807348271 307244 315724 324240 332352 338808 807348273 307246 315725 324241
332356 338815 807348278 307247 316840 324243 332360 339827 807348279 307248
316847 324245 332374 339830 807348280 307252 316979 324256 332690 339831
807348281 307255 316984 325724 332699 339838 807348283 307770 316991 325740
332710 339839 807348286 307771 317220 325742 332715 339841 807348287 307772
317223 325745 332729 339842 807348288 307773 317235 325756 333368 339843
807348292 307777 317253 325775 333372 340048 807348293 307782 317662 325777
333373 340049 807348294 308093 317664 325778 333374 340053 807348296 308100
317668 327115 333375 340054 807348704 309466 321294 327122 333376 804344578
807348709 309469 321300 327133 333377 804344579 807348714 309470 321448 327136
333379 804345552 807348715 309475 321457 321652 333380 805346232 807348719
309476 321615 321656 333381 805346239 807348728 310273 321617 321662 333382
340067 807349080 310276 321622 321663 333385 340760 807349088 and 310277 321623
321664 333390 340767 310282 321625 321665 335825 340779 313712 321627 322846
336155 340781
RECALLING FIRM/MANUFACTURER Boston
Scientific Corporation, Fremont , CA
REASON Computer
malware:
Products may be infected with a worm (computer malware) which could infect a
computer network to which it may be connected.
VOLUME OF PRODUCT IN
COMMERCE 482 units
DISTRIBUTION Nationwide, Europe, Middle East, Africa, and Japan
.
PRODUCT
a) Arjo Maxi 500 Patient Lift with
2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. Model KM560101,
and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with
the optional scale kit 700.05505. The Maxi 500 is a mobile passive lifter,
intended to be used for lifting and transferring of patients in hospitals,
nursing homes of other health care facilities,
b) Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning
System) and Scale. A Non-AC-Powered Patient Lift. Model KM560181 and Model
KM560081 - Maxi 500 with 4-Point Spreader Bar, if it was equipped with the
optional scale kit 700.19251,
CODE
a) Serial numbers: KM5611219, KM5611322, KM5611076, KM5610713,
KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551,
KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006,
KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013,
KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020,
KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027,
KM5611084, KM5610813, KM5611290, KM5610667, and KM5611321;
Serial numbers:
SO#5140275 and SO#5156094;
b) Serial numbers: KM5610035,
KM5610036, KM5610037, KM5610038, KM5610039, KM5610040, KM5610041, KM5610042,
KM5610043, KM5610044, KM5610045, KM5610046, KM5610047, KM5610048, KM5610049,
KM5610050, KM5610051, KM5610052, KM5610053, KM5610054, KM5610055, KM5610056,
KM5610057, KM5610058, KM5610059, KM5610060, KM5610061, KM5610062, KM5610063,
KM5610064, KM5610065, KM5610066, KM5610096, KM5610097, KM5610098, KM5610099,
KM5610100, KM5610101, KM5610102, KM5610103, KM5610104, KM5610105, KM5610106,
KM5610107, KM5610108, KM5610109, KM5610110, KM5610111, KM5610112, KM5610113,
KM5610116, KM5610117, KM5610118, KM5610119, KM5610120, KM5610121, KM5610122,
KM5610123, KM5610124, KM5610125, KM5610126, KM5610127, KM5610128, KM5610129,
KM5610130, KM5610131, KM5610132, KM5610133, KM5610152, KM5610153, KM5610154,
KM5610155, KM5610156, KM5610157, KM5610158, KM5610159, KM5610160, KM5610161,
KM5610162, KM5610163, KM5610164, KM5610165, KM5610166, KM5610167, KM5610168,
KM5610169, KM5610170, KM5610171, KM5610173, KM5610176, KM5610177, KM5610178,
KM5610179, KM5610180, KM5610181, KM5610182, KM5610187, KM5610235, KM5610236,
KM5610237, KM5610238, KM5610239, KM5610240, KM5610241, KM5610242, KM5610243,
KM5610244, KM5610245, KM5610246, KM5610247, KM5610249, KM5610250, KM5610251,
KM5610253, KM5610254, KM5610257, KM5610260, KM5610261, KM5610262, KM5610263,
KM5610264, KM5610265, KM5610266, KM5610267, KM5610268, KM5610269, KM5610270,
KM5610271, KM5610272, KM5610273, KM5610274, KM5610275, KM5610276, KM5610278,
KM5610280, KM5610281, KM5610282, KM5610284, KM5610285, KM5610286, KM5610288,
KM5610289, KM5610290, KM5610291, KM5610292, KM5610293, KM5610294, KM5610295,
KM5610296, KM5610297, KM5610298, KM5610299, KM5610300, KM5610301, KM5610302,
KM5610303, KM5610304, KM5610305, KM5610306, KM5610307, KM5610308, KM5610309,
KM5610310, KM5610311, KM5610312, KM5610313, KM5610314, KM5610315, KM5610316,
KM5610317, KM5610318, KM5610319, KM5610320, KM5610321, KM5610322, KM5610323,
KM5610324, KM5610325, KM5610326, KM5610327, KM5610328, KM5610329, KM5610330,
KM5610331, KM5610332, KM5610333, KM5610334, KM5610335, KM5610336, KM5610337,
KM5610338, KM5610339, KM5610340, KM5610341, KM5610342, KM5610343, KM5610406,
KM5610407, KM5610408, KM5610409, KM5610410, KM5610411, KM5610412, KM5610413,
KM5610414, KM5610415, KM5610416, KM5610417, KM5610418, KM5610419, KM5610420,
KM5610421, KM5610422, KM5610423, KM5610424, KM5610425, KM5610426, KM5610427,
KM5610428, KM5610429, KM5610430, KM5610431, KM5610432, KM5610433, KM5610434,
KM5610435, KM5610436, KM5610437, KM5610438, KM5610439, KM5610440, KM5610441,
KM5610596, KM5610700, KM5610701, KM5610702, KM5610703, KM5610704, KM5610722,
KM5610723, KM5610724, KM5610725, KM5610726, KM5610735, KM5610736, KM5610748,
KM5610749, KM5610750, KM5610751, KM5610752, KM5610753, KM5610754, KM5610755,
KM5610756, KM5610757, KM5610758, KM5610784, KM5610785, KM5610786, KM5610787,
KM5610788, KM5610805, KM5610806, KM5610808, KM5610814, KM5610815, KM5610816,
KM5610817, KM5610818, KM5610824, KM5610825, KM5610826, KM5610827, KM5610828,
KM5610830, KM5610831, KM5610832, KM5610833, KM5610839, KM5610840, KM5610841,
KM5610842, KM5610843, KM5610849, KM5610850, KM5610851, KM5610852, KM5610853,
KM5610854, KM5610855, KM5610856, KM5610857, KM5610858, KM5610878, KM5610879,
KM5610880, KM5610881, KM5610888, KM5610889, KM5610890, KM5610891, KM5610892,
KM5610913, KM5610914, KM5610915, KM5610916, KM5610950, KM5610951, KM5610952,
KM5610953, KM5610954, KM5610978, KM5610980, KM5610981, KM5610982, KM5610983,
KM5610984, KM5610985, KM5610986, KM5610987, KM5610988, KM5610989, KM5610990,
KM5610991, KM5610992, KM5610998, KM5610999, KM5611001, KM5611002, KM5611093,
KM5611096, KM5611097, KM5611098, KM5611099, KM5611101, KM5611121, KM5611123,
KM5611124, KM5611125, KM5611137, KM5611138, KM5611139, KM5611187, KM5611188,
KM5611190, KM5611233, KM5611235, KM5611237, KM5611293, KM5611294, KM5611295,
KM5611296, KM5611307, KM5611324, KM5611327, KM5611329, KM5611330, KM5611331,
KM5611395, KM5611396, KM5611402, KM56510015, KM56510016, KM56510017, KM56510018,
KM56510019, KM56510020, KM56510021, KM56510022, KM56510023 and KM56510024;
Serial numbers: SO#5178400, SO#5143612, SO#5204405, SO#5186264, SO#5137047,
SO#5150226, SO#5156912, SO#5162379, SO#5165403 and SO#5142409
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc.,
Roselle , IL ,
Manufacturer: B. H. M.
Medical, Inc., Magog , Canada .
REASON If the spring pin is not properly reinstalled
after maintenance, the pivot bolt could unscrew by itself within a limited
period of time, resulting in a hanger bar detachment.
VOLUME OF
PRODUCT IN COMMERCE
415 lifts; 12 scale kits
DISTRIBUTION Nationwide
PRODUCT Vidiera NsP Nucleic Sample Preparation, Part Number: A22421,
Version 1.0.41,
CODE Version
1.0.41
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Beckman Coulter Inc., Brea , CA ,
Manufacturer: Beckman Coulter Inc., Fullerton , CA.
REASON Incorrect results:
under certain circumstances, when transfer volume is not within the set range,
the Vidiera NsP software does not report sample exclusion and does not flag the
excluded sample in the "Run Results" report.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION Nationwide
PRODUCT ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. ACE EZA1c Reagent is intended for the quantitative determination of stable hemoglobin A1c in human whole blood samples using the ACE and Ace Alera clinical chemistry systems. Measurement of hemoglobin A1c is a viable indicator for long-term diabetic control.
a) EZA1c Reagent ACI-30, and
b) EZA1c Reagent
ACI-30. The following EZA1c control and calibrator kits were included in the
customer notification instructing them to discard the product. There is no use
for these products without the reagent, (EZA1c Controls C2-82, and EZA1c
Calibrators S2-82),
CODE a) Lot #
F2481, Exp. 9/2008 and
b) Lot # F2603, Exp 01/2009;
(Lot # HBC00507-1, Exp.
10/2008 and Lot # HBS00907-1, Exp. 10/2008)
RECALLING
FIRM/MANUFACTURER Alfa Wassermann, Inc., Caldwell , NJ ,
REASON Internal studies observed occasional unexpected
outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c
reagent on the ACE or ACE Alera clinical chemistry systems.
VOLUME
OF PRODUCT IN COMMERCE 917 kits
DISTRIBUTION Nationwide
PRODUCT
a) FHC MicroTargeting Electrode,
MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit
neuronal activity or intra-operative stimulation of neural elements in the
brain,
b) FC4000 MicroTargeting Electrode Kit 5x For
use with Nexframe and Nexdrive. REF: FCH 4000 (5 Prefilled single use kits -5
packages and 2 electrodes each) Intended for use in intra-operative recording of
single unit neuronal activity or intra-operative stimulation of neural elements
in the brain,
c) FC400SP MicroTargeting
StimPilot Single Procedure Kit, Ref: FHC4000SP. Intended for use in
intra-operative recording of single unit neuronal activity or intra-operative
stimulation of neural elements in the brain,
CODE
a) Lot #'s: 47647 and 475611;
b) Lot #: 866051
c) Serial #'s: 01689 through
01708 and 01756 through 01758
RECALLING FIRM/MANUFACTURER
FHC, Inc., Bowdoinham , ME ,
REASON Mislabeled: May
contain an electrode longer than labeled size.
VOLUME OF PRODUCT IN
COMMERCE
256 electrodes
DISTRIBUTION Nationwide and PR
PRODUCT
a) STA Neoplastine CI 10; Product
Catalogue Number: 0666,
b) STA Neoplastine CI Plus 10;
Product Catalogue Number: 0667,
C ODE
a) Lot #'s: 101393, 101465, 101676, and 102269; Lot
b) Lot #'s:
100439, 101126, 101601, 100755, 101231, 101602, 100975, 101419, 101726, 100995,
101420, 101856, 101002, 101600, and 101955
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc.,
Parsippany , NJ ,
Manufacturer: Diagnostica Stago - Taverny Site,
Taverny,
France .
REASON Internal investigation has determined the potential lack of
homogeneity between product vials.
VOLUME OF PRODUCT IN COMMERCE
a) 1,280 units; b) 31,207 units
DISTRIBUTION Nationwide
PRODUCT
Maxi Move, Model NDA0200-20 Batteries
Pack. The equipment is intended to be used in Hospitals, nursing homes, or other
health care facilities by trained caregivers for the transfer of patients. This
battery pack was solely supplied with Maxi Move floor lift model numbers
starting with KCxxx or sold separately as replacement parts,
CODE
Lot #: 070826D
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle , IL
Manufacturer: B. H.M. Medical, Inc., Magog , Canada .
REASON
The battery pack has a defective
connector that could lead to the inability of the battery pack to recharge
and/or short circuit, resulting in smoke emission.
VOLUME OF PRODUCT
IN COMMERCE 273 battery packs
DISTRIBUTION Nationwide
PRODUCT
Single-use sterile puncture attachment
UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro
Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound
scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound
scanner 2101 and Diagnostic Ultrasound Transducer 8667 performing ultrasound
guided biopsies of the prostate,
CODE All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bk Medical, Lierlev , Denmark
Manufacturer: Mepy Systems, Saint Jean , France .
REASON No 510k approved.
VOLUME OF PRODUCT IN COMMERCE 664 units
DISTRIBUTION Nationwide
PRODUCT Cannabinoids Intercept Micro Plate EIA
100 plate kit; Product number 11181C,
CODE Lot # 6609532, Exp: 12/2008
RECALLING FIRM/MANUFACTURER
OraSure Technologies, Inc., Bethlehem , PA
REASON Readings , high: intermittent high
absorbance readings.
VOLUME OF PRODUCT IN COMMERCE 1
kit
DISTRIBUTION NY