APRIL 2008
WEEK ENDING APRIL 5
PRODUCT
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered
external defibrillator with battery backup. Part Numbers: 3202487-073,
3202487-079, 3202488-036,
Physio-Control LIFEPAK 20
defibrillator/monitor, AC powered external defibrillator with battery backup.
Part Numbers: 3202487-073, 3202487-079,
3202488-036,
CODE
Serial Numbers (domestic units):
36133753, 36133760, 36139018, 36139023, 36139030, 36137448, 36138998, 36141356,
36141357, 36141358, 36141360, 36141361, 36141362, 36141363, 36141365, 36141366,
36141367, 36141370, 36141373, 36141378, 36141380, 36141381, 36141382, 36141383,
36141384, 36141393, 36141394, 36141395, 36141396, 36141399, 36141400, 36142717,
36142718, 36142730, 36142731, 36141386, 36141398, 36133739, 36133740, 36133742,
36133743, 36133744, 36133745, 36133746, 36133747, 36133748, 36133749, 36133750,
36133751, 36133752, 36133754, 36133755, 36133756, 36133757, 36133758, 36133759,
36137218, 36137219, 36137220, 36137222, 36137224, 36137225, 36137226, 36137227,
36137230, 36137231, 36137352, 36137353, 36137355, 36137356, 36137357, 36137359,
36137360, 36137361, 36137362, 36137363, 36137364, 36137365, 36137366, 36137367,
36137368, 36137369, 36139002, 36139010 Serial Numbers (international units):
36137354, 36137358, 36137370, 36137371, 36137372, 36138999, 36139000, 36139005,
36139006, 36139007, 36139009, 36139011, 36139012, 36139013, 36139014, 36139021,
36139024, 36139025, 36139031
RECALLING
FIRM/MANUFACTURER Physio Control, Inc., Redmond, WA,
REASON
Inoperable Device - Potential for delay
in therapy or prevention of defibrillation therapy due to corrosion of the
Printed Circuit Board Assemblies (PCBA).
VOLUME OF PRODUCT IN
COMMERCE 103 devices
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Cardiovascular Procedure Kit, P/N: 70932-01, X-coated Pump and
Table Pack, - (the X-coated pump and table pack contains
a weighted flexible sucker, Catalog No.: 804113),
b) Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin
Cardiovascular Services Pump and Table Pack, (the Pump
& table pack contains a weighted flexible sucker,
Catalog No. 804113),
c) Cardiovascular Procedure Kit,
P/N 70295-02, St. Louis University Hospital Pump & Table Pack, (Pump
& table pack contains a weighted flexible sucker, Catalog No. 804113),
d) Cardiovascular Procedure Kit, P/N 70579-04, St.
Louis University Hospital Pump & Table Pack, (the Pump
& Table pack contains a weighted flexible sucker, Catalog No. 804113),
CODE
a) Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05,
GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27,
HM22, HP03 and KA14;
b) Lot Numbers: GF08, GF30, GN06, HA15, HE09, HH02,
HK27, HM01, HM22, HN12, HP17 and KA07;
c) Lot Number:
HM15;
d) Lot Numbers: GC20, GE24, GF22, GG12, GH17, GL25, GN06, HA22, HD19, HF07, HG18 and HM08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems
Corp., Ann Arbor, MI,
Manufacturer:
Terumo Cardiovascular Systems Corp., Ashland, MA.
REASON
Loose Flash at tip of Weighted Flexible
Sucker: A loose strand of stainless steel left on the device during
manufacturing by an outside supplier may result in an unretrieved metal fragment
remaining in the patient.
VOLUME OF PRODUCT IN
COMMERCE 1121
kits
DISTRIBUTION Nationwide
PRODUCT
Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No:
96000,
CODE Lot Numbers: 180263,
187303, 181472, 183607, 181471, 188135, 185593, 186624, 187398, 190790, and
189158
RECALLING FIRM/MANUFACTURER Biosite Inc., San
Diego, CA,
REASON False Lower Results: Toxin A
results in the Triage Micro C. difficile Panel have shown falsely lower visual
signals (color strength) in certain lots compared to results observed with
previous lots.
VOLUME OF PRODUCT IN COMMERCE 4,549
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150,
A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the
quantitative
determination of alkaline phosphatase in serum,
b)
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of
alkaline phosphatase in serum,
c) Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro
diagnostic,
d) Liquid Alk
Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic,
e) Liquid Alk Phos R2
Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic,
f) Alk Phos R1 (also labeled as Alkaline
Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120,
7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic,
50 mL, 120 mL , 2 L and 500 mL containers, ,
g) Alk
Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog
Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In
vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL
containers,
h) Liquid Alkaline Phosphatase Reagent Set;
Catalog No. A7516-150-SAM, In vitro diagnostic; for the
quantitative determination of alkaline phosphatase in serum,
CODE All lots
beginning with 727801; exp. 4/09
RECALLING
FIRM/MANUFACTURER Pointe Scientific, Inc., Canton, MI,
REASON
Product may be contaminated with
microorganisms.
VOLUME OF PRODUCT IN COMMERCE 262 sets
plus 40.2 L bulk
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75
Sizing Wing; The device is a preparatory instrument used
for femoral knee insertion,
b)
Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing, Biomet UK Ltd, Made in Britain; The device
is a preparatory instrument used for femoral knee
insertion. (Distributed to Puerto Rico),
CODE
a) Lot #: 212910;
b) Lot #:
1162107
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw,
IN,
REASON The instrument’s sizing line is in the
wrong place.
VOLUME OF PRODUCT IN COMMERCE 36
units
DISTRIBUTION Nationwide and Canada
PRODUCT
a)
Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal),
b)
Osmocoll, COP
Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low),
CODE
a) Lot Numbers: 6 units packages:
0256118, 0256131, 0256151, 0256195, 0256213, 0256248, 0256306, 0256354,
0257016, 0257113, 0257032, 0257071, 0257150, 100299, 100500, 100677, and 100183:
Individual vials Lot Numbers: I-61-22 , expiration 4/08 and I-62-34, expiration
10/08; Only individual vials of SS-025 (Lot I-62-34, expiration 10/08 ) included
in Osmocoll SS-039 of 6 unit package Lot Numbers: 0397032 and 100455;
b) Lot
Numbers: 100136, 100445, and 100558; Individual vials Lot Numbers: I-65-18, expiration 9/09 (low control) and I-65-19, expiration
7/09 (high control)
RECALLING FIRM/MANUFACTURER Wescor,
Inc., Logan, UT,
REASON Inaccurate readings; The control does
not provide an accurate calibration value/readings when performing Colloid
Osmotic Pressure (COP) testing.
VOLUME OF PRODUCT IN
COMMERCE 1,025 1 mL glass
vials
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm,
b) BIOMET 3i LOCATOR ABUTMENT,
Catalog/Item Number: LOA003, 3.0mm,
CODE
a) Lot Number: 765291;
b) Lot Number:
765295
RECALLING FIRM/MANUFACTURER Biomet 3i, Inc., Palm
Beach Gardens, FL,
REASON Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and
visa versa.
VOLUME OF PRODUCT IN COMMERCE 197
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT BIOMET 3i Certain MicroMiniplant Straight Healing Abutment,
Model/Item Number: ISMHA32, 3.4mm(D) X Omm(P) X 2mm(H),
CODE
Lot Number:
593025-5
RECALLING FIRM/MANUFACTURER Biomet 3i, Inc.,
Palm Beach Gardens, FL,
REASON The Micro-miniplant Straight Healing
Abutments do not fully seat onto the restorative platform of the implant leaving
a gap between the abutment and the implant.
VOLUME OF PRODUCT IN
COMMERCE 270 units
DISTRIBUTION Nationwide
and Internationally
WEEK ENDING APRIL 12
PRODUCT Hill-Rom
Affinity 4 Birthing Bed; Model P3700B,
CODE All units manufactured prior to November
20, 2007; all beds with serial numbers below 1232AA6856
RECALLING
FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN,
REASON
Brake failure: The brakes may not hold or
lock properly.
VOLUME OF PRODUCT IN COMMERCE 1,796
beds
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy
Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180,
b) Coloplast Elefant Suction/Irrigation Cannula for
Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170,
Recall # Z-0714-2008;
c) Coloplast Elefant Suction/Irrigation Tubing, Part
Number: AST 307,
CODE
a) All un-expired lots are being
recalled. ASP 105 ASP 145: Lot Serial # 7030294
ASP14502001 ASP14504101517 ASP14504023142 ASP1455022514
ASP1454110199 ASP14503019 ASP14502001 ASP14503019 ASP14503017
ASP14503019 ASP14503017 ASP14502001
ASP14503017 ASP14502001 ASP14504023142 ASP14504101517
ASP14504023142 ASP14504101517
ASP14504110200 ASP1455022514 ASP1454110199 ASP1455031783
ASP1454110199 ASP1455031783 ASP1455041217 ASP1454110199
ASP1455041217 ASP1455052183 ASP1455041217 ASP1455033506
ASP1455041217 ASP1455052183 ASP1455041217 ASP1454110199
ASP1455041217 ASP1455052183 ASP1454110199 ASP1455052183 ASP 150:
Lot serial # ASP15002001 ASP 180: Lot Serial #7044270 7044267
04041932;
b) All un-expired lots are being recalled. ASP 165: Lot Serial#
04023897 6120192 7021217 7053185 7062896 7062897 7062903 7070016 ASP16502002
ASP16502005 ASP16503040 ASP16503043 ASP16503101459 ASP16503110460 ASP16504023143
ASP16504023897 ASP16504033803 ASP16504061589 ASP16504064478 ASP16504070805
ASP16504074192 ASP1655021255 ASP1655030739 ASP1655031634 ASP1655042461
ASP1655051481 ASP1655052172 ASP1655052174 ASP1655052175 ASP1655052651
ASP1655053628 ASP1655060297 ASP1655060299 ASP1655062276 ASP1655062277
ASP1655070732 ASP1656100365 ASP1656100366 ASP1656120191 ASP1657010843
ASP1657021217 ASP 170: Lot Serial # ASP1701000;
c) All un-expired lots are
being recalled. AST 307: Lot Serial# AST30702104
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Coloplast Corporation,
Minneapolis, MN,
Manufacturer:
Coloplast Manufacturing France SAS, Sarlat, France.
REASON
Lack of sterilization assurance:
Sterilization of Elefant Suction-Irrigation Devices is not performed according
to ISO 11135 standard.
VOLUME OF PRODUCT IN COMMERCE 717
units
DISTRIBUTION Nationwide
PRODUCT Stryker ACL Workstation slider, Model Number: 234-010-503,
CODE
Lot Numbers: 55-059169, 55-059965,
45165M-3, 44252M-1, and 44660M-1
RECALLING
FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA,
REASON
Slider Lock Failure - The ACL Workstation
slider, a component of the ACL workstation, does not consistently lock into the
ACL Workstation Base.
VOLUME OF PRODUCT IN COMMERCE 142
sliders
DISTRIBUTION Nationwide and
Internationally
PRODUCT Agfa IMPAX CardioVascular Suite Results Management Nuclear
Reporting Module, Outbound Report, Model/Catalog No.: L7W1P,
CODE
Software Versions: 2.04.17, 2.04.19 and
2.04.20
RECALLING FIRM/MANUFACTURER AGFA Corporation,
Greenville, SC,
REASON Reporting Differences: The
Outbound Report software produces an Outbound Report (text version) which does
not contain all the clinical content elements present in the PDF version of the
report, also generated on the Nuclear Cardiology Reporting
Module.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION DC, NY, OH, TN, and
VA
PRODUCT Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number:
20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system,
CODE
Lot Numbers 121907002B,
010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and
020608002A
RECALLING FIRM/MANUFACTURER Nanosphere, Inc.,
Northbrook, IL,
REASON Aberrant Results: A warfarin 2C9*2 mutant
capture signal was found to be high enough to result in an aberrant result
(i.e., wild-type called heterozygous).
VOLUME OF PRODUCT IN
COMMERCE 624
units
DISTRIBUTION Nationwide
PRODUCT
a) Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL
vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on
vial),
b) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25,
(NDC-0641-0393-21; on vial),
c) Baxter HEP-LOCK
(Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25
pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial),
d) Baxter HEP-LOCK (Heparin Lock Flush Solution,
USP), 10
units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC
0641-2442-41; on vial),
e) Baxter HEP-LOCK
(Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25,
(NDC 0641-0387-21; on vial),
f) Baxter HEP-LOCK (Heparin Lock Flush Solution,
USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0389-25, (NDC 0641-0389-21: on vial),
g) Baxter
HEP-LOCK
(Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45,
(NDC 0641-2436-41; on vial),
h) Baxter HEP-LOCK (Heparin Lock Flush Solution,
USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial),
i) Baxter
HEP-LOCK
(Preservative-Free Heparin Lock Flush Solution, USP) 10
units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial),
j) Baxter HEP-LOCK
(Preservative-Free Heparin Lock Flush Solution, USP) 100
units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial),
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare Corp., Round Lake, IL,
Manufacturer: Baxter
Healthcare Corporation, Cherry Hill, NJ. REASON Due to an increase of adverse events in
Baxter single and multi-dose Heparin for injection products, which used the same
active pharmaceutical ingredient (API) source as the HEP LOCK
products
VOLUME OF PRODUCT IN COMMERCE 4,603,297
vials
DISTRIBUTIONNationwide and
Internationally
PRODUCT
a) Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material
Number: 019490035, with control console
software versions 6.5/7.2, 8.0, 9.0 and 9.1,
b) Mevatron KD2 Medical Linear Accelerator, Material Number:
01940753, with control console software versions 6.5/7.2,
8.0, 9.0 and 9.1,
c) Primus Plus Medical Linear
Accelerator, Material Number : 4504200, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
d)
Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912,
with control console software versions 6.5/7.2, 8.0, 9.0
and 9.1,
e) Oncor Impression Medical Linear
Accelerator, Material Number : 5857920, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
f)
Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions
6.5/7.2, 8.0, 9.0 and 9.1,
g) Oncor Expression Medical
Linear Accelerator, Material Number: 07360717, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
h) Mevatron KD-2 Medical Linear Accelerator, Material Number:
8515520, with control console software versions 6.5/7.2,
8.0, 9.0 and 9.1,
i) Mevatron KDS-2 Medical Linear
Accelerator, Material Number: 9822693, with control
console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
j)
Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
k) MEVATRON M-2 6300 Medical Linear Accelerator,
Material Number: 09401316 with control console software
versions 6.5/7.2, 8.0, 9.0 and 9.1,
l) Mevatron MD2
Medical Linear Accelerator, Material Number: 09401654, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
m) Mevatron KDS-2 Medical Linear Accelerator, Material
Number: 09411588, with control console software versions
6.5/7.2, 8.0, 9.0 and 9.1,
n) Mevatron KDS-2 Medical
Linear Accelerator, Material Number: 09822685, with
control console software versions 6.5/7.2, 8.0, 9.0 and 9.1,
CODE
a) Serial Numbers: 3978 70-4188 3016
3512 3208 3873 2767 2792 2855 2959 3133 31623228 3296 3364 3439 3482 3702
3788 3986 3616 2526 2758 2847 3009 3103 3435 3541 3859 3931 3433 3805 3842 3618
70-4287 3055 3678 3495 3798 3258 3285 3294 3617 3736 3425 3748 70-4146 3084 2961
2955 70-4363 3383 2596 3089 3274 3448 2784 3316 3604 3629 3639 4018 5092 2722
2834 3756 2968 3353 3605 70-4316 2738 2845 2965 3136 5114 70-4323 2816 2913 3243
3138 3826 2901 3624 3699 2806 2875 3774 3557 2765 3303 3623 70-4178 3156 3458
3673 3246 3251 3491 3108 3857 3903 3911 3376 4063 2803 2804 3321 3394 3923 2673
2748 2822 2881 2953 2984 3015 3197 3314 3328 3363 3415 3885 3726 3869 3928 3196
3198 3252 3344 3508 3532 3563 3637 3874 4014 4023 4025 5009 5019 5051 5070
70-4104 70-4191 70-4261 4375 70-3388 4087 3352 3607 3613 3687 3849 3851 3921
3935 3992 4044 5075 5078 5106 5107 5111 70-4199 70-4211 70-4245 70-4259 70-4265
70-4286 70-4293 70-4294 70-4321 70-4337 70-4353 70-4355 70-4377 70-4382 70-4385
3659 3271 3551 3707 5067 70-4249 70-4254 70-4367 2895 3765 3566 70-4304 3374
3428 3445 3498 4056 5052 70-4182 3914 2947 3449 3293 3546 5071 70-4242 3496 and
5109;
b) Serial Numbers: 2568 2698 2589 2038 2448 2547 2681 2686 2781 2592
and 2726;
c) Serial Numbers: 3479 70-4347 3014 3574 2972 3365 3377 3564 2828
3942 3102 2941
3212 3215 3286 3305 3324 3342 3354 3418 3595 3667 4059 3272
3899 2839 2991 3154 3533 3572 3583 3679 3862 3922 3924 4036 2914 3168 3474 3542
3027 3153 3255 3318 3514 3622 3672 3675 3835 3423 3244 3524 3602 3696 3403 3471
3979 2911 3019 3114 3213 3049 3174 3179 3257 3731 3773 3832 3949 2996 3701 2836
2867 3087 3597 3068 3223 3601 2931 3484 2827 3075 3077 3142 3264 3427 3461 3519
3657 3004 3477 3547 2896 3112 3211 3651 3711 3745 4001 3105 3137 2934 3131 3186
3323 3417 3568 3292 2863 2894 3125 3134 3319 3349 3414 3504 3634 3695 3781 2768
3666 3825 3452 2701 2933 3039 3092 3402 3426 3569 2893 3069 3111 3079 3181 3565
70-4185 3239 3515 3516 3453 2899 3214 3751 2823 2846 2954 3456 3709 3203 3424
3245 3443 2912 2958 3261 3267 3297 3392 3413 3534 3241 3224 3829 2887 3011 2733
3727 3728 2956 2963 3579 3582 3663 2815 2964 3046 3217 3308 3724 3752 3042 3158
3191 3284 3291 3295 3356 3378 3382 3406 3407 3619 3638 3641 3645 3742 3919
70-4173 3612 3824 3995 2869 3219 3343 3502 2753 2987 3398 3522 3814 2782 2783
2796 2829 2832 2833 2938 2944 2945 2948 2973 2994 3033 3034 3072 3098 3106 3128
3144 3333 3348 3351 3362 3387 3399 3438 3467 3539 3549 3614 3693 4013 3444 3936
3499 3577 3725 3786 3794 3977 4042 2785 3408 3421 3475 4039 5036 70-4271 2844
3148 3189 3237 3262 3278 3336 3359 3436 3488 3529 3531 3677 3717 3813 3822 3839
3844 3867 3868 3872 3876 3902 3943 3985 3991 4033 4043 4047 4055 4057 4085 5010
5021 5050 5066 5077 5079 70-4102 70-4206 70-4219 70-4225 70-4247 70-4252 70-4275
70-4351 70-4364 70-4103 3347 3386 3389 3994 4045 3028 3722 70-4195 3483 3506
3562 3698 3489 3492 3248 3299 3455 3468 3646 3669 3762 3831 3915 3947 3976 5043
5047 5076 70-4116 70-4162 70-4198 70-4212 70-4237 70-4255 70-4279 70-4315
70-4318 70-4322 70-4341 70-4376 3594 3746 3384 3283 70-4282 3893 4004 3123 3216
3584 3734 2924 3024 3606 3608 3909 70-4139 70-4141 70-4251 2883 2986 3036 3095
3159 3242 3391 3454 3543 3553 3556 3621 3636 3653 3654 3661 3662 3772 3967 3969
4006 4028 5045 5046 70-4112 70-4192 70-4285 3017 2966 3064 3797 3008 3218 3375
3567 5097 3507 3759 4086 5003 5110 70-4256 3288 3113 3238 3405 3481 3691 3706
3708 3721 70-4302 3587 3592 3732 3861 70-4126 3767 3231 3332 3578 3686 3833
70-4308 3999 3369 3401 3412 3002 3273 3276 3005 3462 4076 2878 3329 3897 3493
3465 and 3719;
d) Serial Numbers: 4065 70-4306 3764 3964
3803 5093 70-4119 70-4144 70-4145 70-4177 70-4343 3801
70-4222 3955 70-4161 4019 5033 70-4142 4067 70-4122 3783
3901 3791 3793 70-4262 5096 3888 70-4172 70-4174 70-4317 70-4378
3802 3953 3804 70-4354 70-4356 3815 3948 70-4135 3753 3846
3907 3975 3998 3761 4072 3981 70-4166 4035 70-4345
70-4362 3989 70-4175 4015 70-4159 70-4157 70-4349 3877
3754 3755 70-4129 3769 3957 5060 70-4183 3778 5088 5098 3855 70-4379 4091 4011 70-4136 70-4154 70-4334 4024 3796 3799
3865 70-4361 3795
5034 5057 5059 5105 3808 4022 4068 4081
5032 5058 5086 5102 70-4132 70-4147 70-4149 70-4153
70-4189 70-4288 70-4331 70-4366 70-4158 3823 3965 5061 5091 70-4124 70-4137 70-4329 70-4348 5068 70-4215 70-4253
70-4272 70-4305 70-4335 70-4338 70-4176 70-4209 3816 4012
4053 70-4186 70-4241 70-4244 3858 3963 4002 4027 70-4346
4071 3836 3827 4005 5039 5040 70-4231 5030 70-4328 70-4365
4026 4009 3916 5084 70-4278 3925 3954 5027 5069 5104
70-4224 70-4295 70-4299 5101 704093 3968 4037 70-4193
70-4292 70-4127 3841 4062 4064 4074 5002 4017
4084 4096
5001 5011 5053 5087 5095 70-4107 5031 3983 5081 5085 5023 3776 3848 70-4097 70-4258 70-4301 5004 3863 and 4008;
e)
Serial numbers; 4078 70-4143 70-4257 3878 70-4344 70-4207 70-4235 4021 70-4296 70-4165 70-4167 3729 5022 5035 5074 3811 3845 5108
70-4238 70-4386 3894 4048 70-4276 70-4277 70-4281 70-4083
3974 3962 3973 70-4152 and 3883;
f) Serial Numbers: 3576 3938 70-4283 3738
3817 3987 3988 4095 70-4368 4016 3904 3926 4079 4082
70-4077 70-4113 70-4197 3905 3934 3852 3737 3758 3856 3891 3929 3937 70-4163 3895 3896 4049 70-4201 70-4184 5038
70-4213 70-4223 5012
70-4311 3932 3739 3806 3884 3912
3941 70-4297 70-4314 and 70-4217;
g) Serial Numbers: 5120 5037 5041 5042 and
5094;
h) Serial Numbers: 2579 2756 2175 2645 2743 2614 2646 1938 2652 and
2376;
i) Serial Numbers: 2518 and 2289;
j) Serial
Numbers: 3151 3163 3104 3371 and 3497;
k) Serial Number: 2703;
l) Serial
Numbers: 2427 2661 and 2937;
m) Serial Number: 2453;
n) Serial Numbers:
2131 and 2444
RECALLING FIRM/MANUFACTURER Siemens
Medical Solutions USA, Inc., Concord, CA,
REASON Linear
accelerator gantry may rotate in an unexpected direction and may cause patient
injury on impact.
VOLUME OF PRODUCT IN COMMERCE 952
units
DISTRIBUTION Nationwide and Internationally
PRODUCT BIOMET
3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H),
Sterile,
CODE Lot Number:
770147
RECALLING FIRM/MANUFACTURER Biomet 3i, Inc., Palm
Beach, FL,
REASON Mis-labeling: Labeled THA53
device packaging may contain ITHA53 devices (The ITHA53 is designed to be used
with an internally hexed implant. The THA53 is used with an external hex
platform).
VOLUME OF PRODUCT IN COMMERCE 254
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING APRIL 19
PRODUCT BD FACS
Sample Prep Assistant II, Part Number: 337170,
CODE Serial Numbers: T0246 to T0290 (except
for T0274, T0275, T0277 and T0279)
RECALLING
FIRM/MANUFACTURER BD Biosciences, San Jose, Ca,
REASON
Mixing Performance: SPA II devices
manufactured with the affected product motor control board may exhibit
suboptimal mixing performance.
VOLUME OF PRODUCT IN
COMMERCE 31 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery
Device, Catalog No. 840-840, Sterile, Made In Israel,
CODE Lot number:
61280807
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Lumenis, Inc., Salt Lake City, UT,
Manufacturer: Lumenis Limited,
Yokneam, Israel.
REASON Incorrect Label: The Units
outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed
to the product indicated that it is a 365 micron fiber. The micron fiber
contained in the inner pouch is 200 micro fiber. The inner product is mislabeled
with the wrong size.
VOLUME OF PRODUCT IN COMMERCE 59
units
DISTRIBUTION MA
PRODUCT
a) Myelotec® Steerable Video Guided Catheter, 2.7mm, (product code:
2000),
b) Myelotec® Steerable
Video Guided Catheter, 3.0mm, (Product Code: 2010),
CODE
a) Label Inserts: LB0013-1,
LB0013-2, and LB0013-3;
b) Label Insert: LB0020-0, LB0020-1, LB0020-2,
LB0020-3, and LB0020-4
RECALLING
FIRM/MANUFACTURER Myelotec, Inc., Rosewell, GA,
REASON
Incorrect Labeling
information: Product may contain inappropriate information in its label insert
that refers to the product's use with energy delivering
instrumentation.
VOLUME OF PRODUCT IN COMMERCE 1,252
shipping containers
DISTRIBUTION Nationwide and
Internationally
PRODUCT Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with
the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models
including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240,
IEXC131355, ILXC1212135, ILXC1616115, AEXC242440, IEXC141455, ILXC121285,
ILXC1616135, AEXC262640, IEXC151555, ILXC1313115, ILXC161685, AEXC282840,
IEXC161655, ILXC1313135, ILXC1620115, BFXC2012135, IEXC162085, ILXC131385,
ILXC1620135, BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, BFXC2213135,
IEXC182285, ILXC1414135, ILXC1818135, BFXC2213165, IEXC182485, ILXC141485,
ILXC181885, BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, BFXC2414165,
ILXC1515135, ILXC1822135, BFXC2615135, ILXC1824115, BFXC2615165, ILXC1824135,
BFXC2816135, ILXC2020115, BFXC2816165, ILXC2020135, ILXC202085; CODE
All codes
RECALLING
FIRM/MANUFACTURER Medtronic CardioVascular, Santa Rosa, CA,
REASON
Sterility compromised: Device sterility
may be compromised as evidenced by a loss of outer package
integrity.
VOLUME OF PRODUCT IN COMMERCE 7,000
units
DISTRIBUTION Nationwide
PRODUCT ConMed
Linvatec, Ultrapower Burs,
CODE
Lot Numbers: BBD14805 BBD14542 BBD14804
00949613 BBD08721 BBD11468 BBD14258 BBD15139 BBD16978 BBC91085 BBD08725 BBD11465
BBD13560 BBD14265 BBD14533 BBD17117 BBD18411 BBD08940 BBD11470 BBD13564 BBD14680
BBD14711 BBD18412 BBD08939 BBD15429 BBD15591 BBD16681 BBD14944 BBD17632 BBD17835
BBD08961 BBD17399 BBD08935 BBD14264 BBD15416 BBD17423 BBD14935 BBD17832 BBD08942
BBD14261 BBD17633 BBD08448 BBD13158 BBD16029 BBD08943 BBD13565 BBD16122 BBD17627
BBD08389 BBD14260 BBD15401 BBD16652 BBD11471 BBD14266 BBD14658 BBD17631 BBD17836
BBD08443 BBD13567 BBD14747 BBD08445 BBD13569 BBD17896 BBD08959 BBD17626 00950532
BBD08936 BBD13570 BBD08972 BBD15179 BBD08473 BBD13571 BBD14242 BBD15398 BBD17550
BBD08957 BBD08974 BBD16653 BBD08482 BBD17609 BBD08442 BBD15426 BBD16654 BBD08976
BBD14955 BBD08452 BBD09167 BBD14257 BBD16045 BBD08446 BBD15191 BBD16655 BBD08483
BBD15393 BBD16656 BBD08952 BBD11469 BBD16658 BBD17602 BBC89881 BBD08444 BBD16657
BBD17442 BBD08531 BBD15084 BBD17629 BBD14255 BBD14538 BBC92804 BBD15644
BBD16832
RECALLING FIRM/MANUFACTURER Linvatec, Corp.,
Largo, FL,
REASON Compromised sterility: ConMed Linvatec
medical devices packaged within a certain Peel Pouch Sterile Package may have
compromised sterility due to an improper seal.
VOLUME OF PRODUCT IN
COMMERCE 1,181 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT CES Ultra, Cranial Electrotherapy Stimulator,
CODE
Serial Numbers: 1000 through
3999
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Neuro-Fitness LLC, Fall City, WA,
Manufacturer: Arco Electronics Limited, Hong Kong, Hong Kong
SAR.
REASON No FDA clearance for
the .35Hz/.45Hz frequency option on device.
VOLUME OF PRODUCT IN
COMMERCE 2,020 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Nonin Model 2500 PalmSAT handheld pluse
Oximeter,
CODE
Lot #’s: 500222509 500207705 500222537
500222539 500222540 500222541 500222542 500222546 500222547 500222548 500222552
500222554 500222572 500222592 500222594 500222595 500207668 500207669 500207684
500222521 500222525 500218324 500218325 500218331 500218332 500218333 500218335
500218337 500218338 500218340 500218346 500222496 500222507 500218319 500218320
500207666 500218365 500218334 500218339 500218368 500218377 500218378 500222497
500222502 500222506 500222511 500222513 500207691 500207698 500207703 500207667
500222522 500222523 500207675 500207678 500207679 500207685 200207689 50207693
500207704 500222492 500222498 500222501 500222504 500222508 500222512 500222518
500222527 500222538 500222544 500222545 500222549 500222550 500222551 500222556
500222558 500222559 500222560 500222561 500222562 500222576 500222579 500222580
500222591 500222592 500222593 500207663 500207670 500207673 500207674 500207676
500207682 500207683 500207686 500207687 500207688 500218321 500218322 500218323
500218326 500218327 500218328 500218329 500218330 500218341 500222510 500207695
500207696 500207697 500207707 500207708 500222500 500222543 500222553 500222555
500222564 500222578 500222524 500222526 500218362 500218363 500218364 500218366
500218369 500218370 500218373 500218376 500222493 500222494 500222528 500222529
500222530 500222534 500222491 500222499 500222516 500222517 500207649 500207651
500207652 500207653 500207654 500207655 500207656 500207657 500207658 500207659
500207660 500207661 500207662 500207663 500207664 500207665 500207071 500207672
500207680 500207681 500218349 500218350 500218351 500218354 500218355 500218356
500218358 500218359 500218360 500218361 500218367 500218374 500222477 500222478
500222479 500222480 500222481 500222482 500222483 500222484 500222485 500222486
500222487 500222488 500222489 500222490 500222495 500222503 500222505 500222514
500222515 500222519 500222520 500222531 500222532 500222533 500222535 500222536
500222574 500222577 500222582 500222583 500222584 500222585 500222586 500222587
500222588 500222589 500222590 500222596 500207677 500207692 500207694 500207699
500207700 500207701 500207690 500207702 500218336 500218342 500218343 500218344
500218345 500218347 500218348 500218352 500218353 500218357 500218370 500218372
500218375 500222557 500222563 500222565 500222566 500222567 500222568 500222569
500222570 500222571 500222573 500222575 500222581
RECALLING
FIRM/MANUFACTURER Nonin Medical, Inc., Plymouth, MN,
REASON
Incorrect Label: The label on the back of
the device may show Model 2500A rather than Model 2500.
VOLUME OF
PRODUCT IN COMMERCE 240
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner,
Part Number 740-0322,
CODE Lot #
2792584
RECALLING FIRM/MANUFACTURER Ormco Corporation,
Glendora, CA,
REASON Mislabeled: Product mislabeled with
incorrect expiration date. Expiration date labeled as 2010/07 instead of
2009/07.
VOLUME OF PRODUCT IN COMMERCE 4
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Zimmer Hemovac Wound Drainage Device Infection Control Kits,
Catalog
Number/REF: 00-2550-001-10, 400 ml INF. Control
Kit w/ 3/32" drain, 2.4 mm,
7Fr, PVC, 107 cm, small,
sterile, latex free, Rx only; Sold in packages of 10,
which contain packages of 1 and 5,
b) Zimmer Hemovac
Wound Drainage Device Infection Control Kits, Catalog Number/
REF 00-2550-002-10, 400 ml-INF. Control Kit w/ 1/8"
drain, 3.2 mm, 10Fr, PVC, 107
cm, medium, sterile, latex
free, Rx only; Sold in packages of 10, which contain
packages of 1 and 5;
c) Zimmer Hemovac Wound Drainage
Device Infection Control Kits, Catalog
Number/REF
00-2550-003-10; 400 ml INF. Control Kit w/ 3/16" drain, 4.8 mm, 15Fr,
PVC, 107 cm, soft, sterile, latex free, Rx only; Sold in
packages of 10, which contain
packages of 1 and 5;
d) Zimmer Hemovac Wound Drainage Device Infection Control
Kits, Catalog
Number/REF 00-2550-004-10; 400 ml INF.
Control Kit w/ 1/4" drain, 6.4 mm, 19Fr,
PVC, 107 cm,
large, sterile, latex free, Rx only; Sold in packages of 10, which
contain packages of 1 and 5; 8;
e)
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/
REF 00-2550-050-10; 400 ml Infection Control Comp. Kit,
sterile, latex free, Rx
only; Sold in packages of 10,
which contain packages of 1 and 5;
f) Zimmer Hemovac Wound Drainage Device Infection Control Kits,
Catalog Number/
REF 00-2550-702-10; 400 ml INF. Control
Kit w/ 1/8" Drain Spec., 3.2mm, 10Fr.,
PVC, 107cm,
medium, sterile, latex free, Rx only; Sold in packages of 10, which
contain packages of 1 and 5;
g)
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
Number/REF 00-2550-703-10; 400 ml INF. Control Kit w/
3/16" Drain Spec.,
4.8mm, 15Fr., PVC, 107cm, soft,
sterile, latex free, Rx only; Sold in packages
of 10,
which contain packages of 1 and 5;
h) Zimmer Hemovac
Wound Drainage Device Infection Control Kits, Catalog
Number/REF 00-2550-704-10; 400 ml INF. Control Kit w/ 1/4" Drain Spec.,
6.4mm., 19Fr., PVC, 107cm, large, sterile, latex free, Rx
only; Sold in packages
of 10, which contain packages of 1
and 5;
i) Zimmer Hemovac Wound Drainage Device
Infection Control Kits, Catalog Number;
47-2550-002-10,
400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.)
O.D. middle perforated PVC drains with trocars, evaluator
tubing and connectors,
medium, contains 10, non-sterile,
latex free,
j) Zimmer Hemovac Wound Drainage Device
Infection Control Kits, Catalog Number;
47-2550-003-10;
400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.)
O.D. middle perforated PVC drains with trocars, evaluator
tubing and connectors,
soft, contains 10, non-sterile,
latex free,
k) Zimmer Hemovac Wound Drainage Device
Infection Control Kits, Catalog Number:
47-2550-050-10;
400 ml evacuators and 450 ml collection bags, evaluator tubing
and universal Y connectors, adapters for silicone drains,
contains 10, non-sterile,
latex-free,
CODE
a) Lots Numbers: 60009294, 60075254,
60101562, 60156041, 60215686, 60271994,
60314032,
60389073, 60440024, 60506573 and 60590575;
b) Lots Numbers: 33440800,
60006818, 60015773, 60025362, 60033385, 60047775,
60051617, 60060757,
60067687, 60072831, 60082265, 60090133, 60096160, 60102772, 60108662, 60118934,
60129193, 60139016, 60147493, 60154829, 60163266, 60171588, 60181669, 60190630,
60196964, 60203044, 60212869, 60223951, 60233568, 60245183, 60252225, 60266735,
60278451, 60288208, 60305457, 60317372, 60323772, 60331175, 60339076, 60346591,
60359577, 60372899, 60382573, 60391905, 60401085, 60409371, 60419370, 60430869,
60444464, 60463237, 60475741, 60488170, 60496915, 60511108, 60530243, 60546074,
60565010, 60578962, 60594499, 60607928, 60622522, 60626621 and 60640519;
c)
Lot Numbers: 60006897, 60030744, 60051038, 60067688, 60075523, 60099441,
60113095, 60134967, 60152075, 60168775, 60184523,
60200854, 60227354,
60240752, 60275128, 60299770,
60329438, 60339077, 60367783, 60385889,
60402652,
60437089, 60493507, 60525201, 60554806, 60581694, 60617399 and
60629984;
d) Lot Numbers: 60006898, 60056511, 60075876, 60107088,
60149880, 60187185,
60238068, 60284223, 60356873,
60406390, 60537533 and 60606313;
e) Lot Numbers: 60006819, 60015774,
60033386, 60045263, 60057329, 60067689,
60084095,
60094656, 60106763, 60116383, 60126841, 60145039, 60158789,
60171589, 60184524, 60200855, 60215687, 60230182,
60240753, 60262574,
60278454, 60294877, 60321541,
60333502, 60342988, 60354480, 60371375,
60385890,
60402653, 60412505, 60437090, 60471395, 60506574, 60520507,
60551036, 60570976, 60590576, 60612123 and
60626622;
f) Lot Numbers; 60004885, 60018681, 60030745, 60045264, 60056512,
60090134,
60101563, 60124258, 60152076, 60189147,
60192877, 60198414, 60217797,
60236478, 60255679,
60281660, 60314033, 60377257, 60402970, 60406391,
60419371, 60444465, 60463238, 60479892, 60511109, 60554807, 60575194,
60586769, 60607929 and 60621372;
g) Lot Numbers:
60045265, 60101564, 60154830, 60196965, 60333503, 60412506,
60453016 and 60633939;
h) Lot Numbers: 60015775,
60033388, 60145040, 60154831, 60198415, 60215688,
60243446, 60377258, 60409373, 60440025, 60471398 and 60640520;
i) Lot
Numbers: 32237200, 32285400, 32326900, 32349300, 32380000, 32413600,
32444100, 32471900, 32503500, 32538000, 32552400,
32580700, 32928800,
32980300, 33043400, 33121100,
33166500, 33222900, 33300500, 33328900,
33387100,
33432000, 60057314, 60075861, 60094646, 60113078, 60117514,
60134951, 60156026, 60176003, 60203020, 60227311,
60249134, 60278438,
60356862, 60389058, 60617386 and
60621549;
j) Lot Numbers; 32331100, 32531400, 32944300, 33078800, 33208400,
33342100,
60006805, 60045252, 60088425, 60118920,
60174047, 60215672, 60269221,
60321524, 60385874,
60540737, 60564969, 60607918 and 60629972;
k) Lot Number: 32256400, 32380100,
33143800, 33234000, 33348300, 33423400,
60047748,
60066632, 60084083, 60116363, 60212361, 60220450, 60266724,
60329424, 60398330, 60456738, 60475725, 60575171,
60581678 and 60612083
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, .
Manufacturer: Zimmer Orthopedic Surgical
Products, Dover, OH.
REASON Leakage: The kits may disassemble at the
fluid collection port, which would present a risk of exposure to blood borne
pathogens to health care providers should it occur during use.
VOLUME
OF PRODUCT IN COMMERCE Approximately 34,354
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT LifeScan
OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for
OneTouch Select and UltraMini (Download) Blood Glucose Meters),
CODE
Part Number only.
RECALLING
FIRM/MANUFACTURER LifeScan, INC., Milpitas, CA, .
REASON
Meter Temporarily Freezes-- A software
compatibility issue may cause the blood glucose meter to cease operations and
freeze temporarily.
VOLUME OF PRODUCT IN COMMERCE 260
customers to date have the recalled software
drivers.
DISTRIBUTION Nationwide
WEEK ENDING APRIL 26
PRODUCT BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated
immunodiagnostic analyzer,
CODE All
software version 2.0, used with Calibrator Lots 86280 and
86290
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories,
Inc., Hercules, CA,
REASON Incorrect values: An error was found in the
BioPlex 2200 Software, Version 2.0 that results in assignment values being
utilized for the BioPlex assay Calibrator Set that may be slightly different
from those printed on the Value Assignment Data Sheet. Some values may be
identical between the lot assignment combinations with the ANA Screen with MDSS
kit.
VOLUME OF PRODUCT IN COMMERCE 85 units of calibrator
lot 86280 and 16 units of calibrator lot
86290
DISTRIBUTION Nationwide, Canada, France, and
Germany
PRODUCT Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement
System Proximal Femoral Resection for Large Segmental Replacements, Femur
Prosthesis Surgical Literature,
CODE Literature number: LSPK41; 10 surgical
protocols per package.
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp, Mahwah, NJ,
REASON
The GMRS Proximal Femoral Surgical
Protocol states " The GMRS Proximal Femoral components are fully compatabile
with all Stryker V40 femoral heads." This statement is incorrect and conflicts
with the Alumina Head label and packaging insert.
VOLUME OF PRODUCT
IN COMMERCE 5,869,
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath:
7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga.,
7.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number:
C-PLI-7.0-35.
b) Peel-Away Introducer set, 7.0 FR,
Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18
ga., 7.0 cm long.
Accepts devices up to
7.0 French, sterile; Catalog Number: C-PLI-7.0-35-X-1,
c) Peel-Away Introducer set, Catheter introducer, sterile;
Catalog Number:
C-PLI-7.0-38-CPC-072491,
d)
Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes
sheath:
7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle:
20XT GA., 4.0
cm long. Accepts devices up to 7.0 French, sterile; Catalog
Number: C-PLIP-7.0-25-
E-MNP,
e) Peel-Away
Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer,
9 CM
long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long.
Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLIP-7.0-35,
f) Peel-Away Introducer set, 7.0 FR; Catheter
introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .035" DIA., 50 CM
long. Accepts devices up to 7.0 French,
sterile; Catalog Number:
C-PLV-7.0-35,
g) Peel-Away Introducer set, 7.0 FR;
Catheter introducer, includes sheath: 7.0 FR.,
15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0
French, sterile;
Catalog Number: C-PLV-7.0-38,
h) Peel-Away Introducer
set without wire guide, 7.0 FR X 15.5 CM. Catheter
introducer, Accepts
devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35,
i) Peel-Away Introducer set without wire guide, 7.0 FR X 15.5
CM. Catheter introducer,
Accepts devices up to 7.0 French, sterile; Catalog
Number: PLVW-7.0-38,
j) Cook TPN Double Lumen
Catheter set; Catheter introducer, includes 6.0 French,
65 CM Silicone
Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA.,
30 CM
long, Needle: 19UT Gage, 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-
65,
k) Cook TPN Single Lumen Catheter set; Catheter
introducer, includes 6.5 French,
90 CM Silicone Catheter, 7.0 FR. Peel-Away
Introducer Set, Wire Guide: .035" DIA.,
30 CM long, Needle: 18 Gage, 7 cm
long, sterile; Catalog Number: C-TPNS-6.5-90-
REDO,
l) Peel-Away Introducer set, 7.0 FR, Catheter introducer,
includes sheath: 7.0 FR., 15.5
CM long, Wire: .038" DIA., 50 CM long, 3 MM J
needle: 18 ga., 7.0 cm long.
Accepts devices up to 7.0 French, sterile;
Catalog Number: C-PLI-7.0-38,
m) Catalog Number:
C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product
is not
distributed in the U.S. and is sent to foreign affiliates who then apply
additional
labeling prior to sale in their countries,
CODE
a) Lot Numbers: F2143720, F2143731,
F2144828, F2147203, F2147788 and F2148621;
b) Lot Numbers: F2121224 and
F2143768;
c) Lot Number: F2118728;
d) Lot Number: F2114652;
e) Lot
Numbers: F2114474 and F2120414;
f) Lot Number: F2143777;
g) Lot Numbers:
F2121943, F2123535, F2127628, F2129263, F2130503, F2131307 and
F2136881;
h) Lot Numbers: 1917513, 1923689 and 1927607;
i) Lot Number:
F2119096;
j) Lot Numbers: F2114684;
k) Lot Number:1926703;
l) Lot
Numbers: 1923714, 1923715, 1923718, 1923719, 1923721, 1923722, 1923723,
1928888, 1928889, 1928891, 1928892, 1928893, 1928894, 1928895, 1928896,
1928897, 1935086, 1935087, 1935089, 1935090, 1935095, 1958841, 1958843,
1958844, 1958847, 1958848, 1958849, 1958850, 1958851 and 1972150;
m) Lot
Number: F2121485
RECALLING FIRM/MANUFACTURER Cook, Inc.,
Bloomington, IN,
REASON Packaging Problem:
The peel-away sheath does not peel uniformly or completely.
VOLUME OF
PRODUCT IN COMMERCE 1,881
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free .
Sterile.
Reorder Number: 309703,
b) BD 10 ml Syringe
Luer Lok Tip, Reorder #3039605,
CODE
a) Lot numbers: 7123237, 7156175,
7156177, 7212946, 7212948, 7239565, 7239566,
7271878;
b) Lot numbers:
7061015, 7061014, 7092726, 7094789, 7094790, 7123223, 7123225,
7150947,
7150949, 7184442, 7184443, 7184446, 7212935, 7239568, 7239570,
7239569,
7271873
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Becton Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Medical Systems, Canaan,
CT.
REASON Defective
Seal; The convenience trays may have open seals, which can adversely impact tray
sterility.
VOLUME OF PRODUCT IN COMMERCE 4,480,660 total
packs
DISTRIBUTION Nationwide
PRODUCT
a) Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal
Drill
Extra Long "R" Attachment, sterile, REF 5160-10-60,
b) Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS
Universal Drill
Extra Long "R" Attachment, sterile, REF 5160-10-75,
c) Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS
Universal Drill
Extra Long "R" Attachment, sterile, Stryker Instruments,
Kalamazoo, MI;
REF 5160-10-90,
d) Stryker 4.7 x 7.9
mm Fluted Drum, Extra Long for use with TPS Universal Drill
Extra Long "R"
Attachment, sterile, REF 5160-20-47,
e) Stryker 6.0 x
7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill
Extra Long
"R" Attachment, sterile, REF 5160-20-60,
f) Stryker
10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, REF 5160-20-105,
g) Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, REF
5160-20-123,
h) Stryker 7.5 x 7.9 mm Fluted Drum,
Extra Long, sterile, REF 5160-20-775,
i) Stryker
6.1 x 8.0 mm Acorn Bur, Extra long, sterile, REF 5160-30-60,
j) Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, REF
5160-30-75,
k) Stryker 9.1 x 11.4 mm Acorn Bur,
Extra Long, REF 5160-30-90,
l) Stryker 3.1 mm x
19.1 mm Straight Router, Extra Long, sterile, REF 5160-70-31,
m) Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use
with extra long "R"
Attachments, sterile, REF 5160-71-223,
n) Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, REF
5160-107-30,
o) Stryker 3.0mm Round Fluted Bur,
Super Long, sterile, REF 5190-10-30,
p) Stryker
4.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-40,
q) Stryker 5.0mm Round Fluted Bur,Super Long, sterile, REF
5190-10-50,
r) Stryker 6.0mm Round Fluted Bur,
Super Long, sterile, REF 5190-10-60,
s) Stryker
7.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-70,
t) Stryker 8.0mm Round Fluted Bur, Super Long, sterile, REF
5190-10-80,
u) Stryker 9.0mm Round Fluted Bur,
Super Long, sterile, REF 5190-10-90,
v) Stryker
10.0 mm Round Fluted Bur, Super Long, sterile, REF 5190-10-100,
w) Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long,
sterile, REF 5190-13-
140,
x) Stryker 5.0 mm XX
Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-
150,
y) Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile,
REF 5190-13-160,
z) Stryker Instruments 7.0mm XX
Coarse Round Diamond Bur, Super Long, sterile,
REF 5190-13-170,
aa) Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super
Long, sterile,
REF 5190-13-180, R
bb) Stryker 6.0 mm
Barrel Bur, sterile, REF 5190-17-60,
cc) Stryker 4.7mm
x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-47,
dd) Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, REF
5190-20-60,
ee) Stryker 10.5mm x 10.7mm Fluted
Drum, Super Long, sterile, REF 5190-20-105,
ff)
Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, REF 5190-20-123,
gg) Stryker 7.8mm x 7.9mm Fluted Drum, Super Long,
sterile, REF 5190-20-775,
hh) Stryker 9.1mm x 7.9mm
Fluted Drum, Super Long, sterile, REF 5190-20-991,
ii) Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long,
sterile, REF 5190-
21-775,
jj) Stryker 9.1mm x 7.9mm
XX Coarse Diamond Drum, Super Long, sterile, REF 5190-
21-991,
kk) Stryker 6.0mm x 8.0mm Acorn Bur, sterile, REF 5190-30-60,
ll) Stryker 7.5mm x 9.5mm Acorn Bur, sterile, REF
5190-30-75,
mm) Stryker 9.0mm x 11.4mm Acorn Bur,
sterile, REF 5190-30-90, 26-2008;
nn) Stryker 3.1mm x 19.1mm
Straight Router, sterile, REF 5190-70-31,
oo)
Stryker 3.0mm x 34.9mm Straight Router, sterile, REF 5190-70-230,
pp) Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for
use with "RX"
attachments, sterile, REF 5190-80-30,
qq) Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long
for use with Long
"AM" attachments, sterile, REF 5230-107-530S1,
rr) Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS
Universal Drill Extra
Long "R" attachment, sterile, REF 5260-10-50,
ss) Stryker Instruments 6.5mm Round Fluted Bur Extra Long for
use with TPS Universal
Drill Extra Long "R" attachment, sterile, REF
5260-10-65,
tt) Stryker Instruments 7.0mm Round Fluted
Bur Extra Long, for use with TPS Universal
Drill Extra Long "R" attachment,
sterile, REF 5260-10-70,
uu) Stryker Instruments Minor
modification product, 550-19-20 W/ 304.8mm length,
sterile, product of
Ireland, REF 5500019020S3,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker
Instruments, Division of Stryker Corporation, Portage, MI,
Manufacturer: Stryker Ireland, Ltd.,
Orthopaedics, Carrigtohill, County Cork, Ireland.
REASON Lack of assurance of
sterility.
VOLUME OF PRODUCT IN
COMMERCE 10,588
DISTRIBUTION Nationwide and
Internationally