FDAFDA · Food and drugs·Recall number Z-3107-2017
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Published September 13, 2017 · Recall initiated: August 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Worldwide Distribution - US (Nationwide) and Internationally to Canada
- Lot
- CATALOG # CS WO (LOT)_# 05A7593 407625 05A7593 412059 05A7593 420879 09-4733A 503927 09-4733A 611913 13-A3858B 588354 13-A3858B 619381 13-A3858B 647955 22-0758B 412013 22-0758B 414835 26-2503 485950 26-2503 604487 26-2503 643270 26-2503 673080 26-2927 407083 26-2927 416194 26-9079A 594214 26-9079A 621261 26-9079A 647250 26-9079A 672502 26-9079A 715637 26A2503 642655 26A2503 655681 26A2503 697266 26A6667B 417410 26B4610B 412369 26B4610B 419333 26-LP1SF 408438 26-LP1SF 408438 26-LP1SF 414819 26-LP1SF 418497 26-LP1SFDF 583577 26-LP1SFDF 595028 26-LP1SFDF 599316 26-LP1SFDF 617603 26-LP1SFDF 620380 26-LP1SFDF 671133 26-LP2SF 412374 26-LP2SF 417223 26-LP2SF 423100 26-LP2SF 423100 26-LP2SFDF 592704 26-LP2SFDF 617604 26-LP3SF 408287 26-LP3SF 412353 26-LP3SFDF 577939 26-LP3SFDF 605345 26-LP4SF 422101 26-LP6SF 419814 26-LP6SF 424210 27-9386A 376178 27-9386A 408314 27-9386A 418220 27-9386A 419957 27-9386A 424866 27-MY1SF 408933 27-MY1SF 414174 27-MY1SF 418498 27-MY1SF 418498 27-MY1SF 425175 27-MY1SFV 377006 27-MY1SFV 408606 27-MY1SFV 414300 27-MY1SFV 420862 28-2961A 420688 28-2961A 420688 28-6031A 406733 28-6031A 415960 28-6031A 419630 28-AR1SF 419285 28-AR1SF 419285 28-AR1SFDF 622878 29-AM1SF 409729 30-9211A 375848 30-CE11SDF 493928 30-CE11SDF 611690 30-CE11SF 368968 30-CE11SF 416765 30-CE11SF 419288 30-CE16SF 417160 30-CE16SF 419449 30-CE16SF 420023 30-CE18SF 415581 30-CE18SF 418823 30-CE1SF 380540 30-CE1SF 407139 30-CE1SF 417154 30-CE1SF 418979 30-CE1SFDF 611688 30-CE1SFDF 647593 30-CE2SFA 415580 30-CE2SFA 416769 30-CE2SFAF 577940 30-CE2SFAF 622818 30-CE3SFDF 622819 30-CE5CSDF 620854 31-0023A 584755 31-0023A 584755 31-0023A 625263 31-7479 378307 31-7479 380125 31-7479A 413934 31-7479A 422011 31-9456 380294 31-9456 414203 31A0585C 406420 31A0585C 412891 31A0585C 419014 31-BM1SF 380701 31-BM1SF 410506 31-BM1SF 414099 31-BM1SF 414823 31-BM1SFDF 577941 31-BM2SFDF 638298 31-BM4SF 421860 32-4688A 409410 32-ST1SF 410793 32-ST1SF 424971 32-ST1SFDF 582266 32-ST1SFDF 608823 HT31BM1SDF 622825 HT31BM2SDF 613333 HT31-BM2SF 414095 HT31-BM2SF 422476 HT31-BM2SF 430704 KAI3BBPKPB 486001 KAI3BBPKPB 488109 KAI3BBPKPB 490970 KAI3BBPKPB 490971 KAI3BBPKPB 491103 KAI3BBPKPD 577983 KAI3BBPKPD 580261 KAI3BBPKPD 580395 KAI3BBPKPD 587291 KAI3BBPKPD 590277 KAI3BBPKPD 591741 KAI3BBPKPD 594384 KAI3BBPKPD 596926 KAI3BBPKPD 598776 KAI3BBPKPD 599997 KAI3BBPKPD 604726 KAI3BBPKPD 605893 KAI3BBPKPD 609130 KAI3BBPKPD 611249 KAI3BBPKPD 614411 KAI3BBPKPD 616442 KAI3BBPKPD 617693 KAI3BBPKPD 617694 KAI3BBPKPD 618796 KAI3BBPKPD 620130 KAI3BBPKPD 622598 KAI3BBPKPD 623531 KAI3BBPKPD 624091 KAI3BBPKPD 624092 KAI3BBPKPD 624729 KAI3BBPKPD 627878 KAI3BBPKPD 629779 KAI3BBPKPD 631398 KAI3BBPKPD 631745 KAI3BBPKPD 635482 KAI3BBPKPD 635585 KAI3BBPKPD 635731 KAI3BBPKPD 636214 KAI3BBPKPD 637857 KAI3BBPKPD 639024 KAI3BBPKPD 640953 KAI3BBPKPD 640954 KAI3BBPKPD 640956 KAI3BBPKPD 642423 KAI3BBPKPD 646067 KAI3BBPKPD 646068 KAI3BBPKPD 648116 KAI3BBPKPD 648145 KAI3BBPKPD 652586 KAI3BBPKPD 656624 KAI3BBPKPD 663737 KAI3BBPKPD 669757 KAI3BBPKPD 670766 KAI3BBPKPD 671283 KAI3BBPKPD 675948 KAI3BBPKPD 677083 KAI3BBPKPD 720642 KAI3BLAKPC 514411 KAI3BLAKPC 580397 KAI3BLAKPC 587629 KAI3BLAKPC 593772 KAI3BLAKPC 600777 KAI3BLAKPC 609135 KAI3BLAKPC 612859 KAI3BLAKPC 618831 KAI3BLAKPC 618831 KAI3BLAKPC 624201 KAI3BLAKPC 627979 KAI3BLAKPC 648254 KAI3BLAKPC 687498 KAI3BLEKPB 499418 MER34INUMG 607113 MER34INUMG 636025 PB08LSGHE 374418 PB08LSGHE 407042 PB08LSGHE 412964 PB08LSGHE 417688 PB08LSGHE 420052 PB08LSGHE 424480 PB33OTMHB 425216 PB41LGBYB 636911 PBMHGRMCO 576988 PBMHGRMCO 588775 PBMHGRMCO 610599 PBMHGYMCO 577420 PBMHGYMCO 623327 PBMHGYMCO 648642 PBMHLSNEF 595197 PBMHLSNEF 616759 PBMHLSNEF 641174 PBMHMGMCZ 576990 PBMHMGMCZ 597038 PBMHMGMCZ 607321 PBMHMGMCZ 622595 PBMHMGMCZ 648585 PBMHMLFBA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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