Reported Oct 18, 2023 · Ongoing
Procedure packs
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Procedure packs
32 of 32 products
| # | Product as published |
|---|---|
| 1 | (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile |
| 2 | (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile |
| 3 | (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile |
| 4 | (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile |
| 5 | (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile |
| 6 | (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile |
| 7 | (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile |
| 8 | (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile |
| 9 | (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile |
| 10 | (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile |
| 11 | (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile |
| 12 | (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile |
| 13 | (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile |
| 14 | (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile |
| 15 | (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile |
| 16 | (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile |
| 17 | (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile |
| 18 | (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile |
| 19 | (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile |
| 20 | (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile |
- Lot codes and dates
35 of 35 products
Products covered by this recall # Barcodes Product as published 1 10195594873332(1) Cat. PC71EXOU7 - Lot #916915, Exp. 5/1/2024, UDI-DI 10195594873332 2 (2) Cat. PVOCMVBLC - Lot #922978, Exp. 10/1/2024 3 10195594763183and Lot #922978, Exp. 7/1/2024, UDI-DI 10195594763183 4 10195594892777(3) Cat. PVRMMVAOH7 - Lot #923996, Exp. 1/1/2024, UDI-DI 10195594892777 5 10195594485894(4) Cat. PV30VPUHA - Lot #898892, Exp. 2/1/2024, UDI-DI 10195594485894 6 10195594882273(5) Cat. SANOCCPDM2 - Lot #920122, Exp. 6/1/2025, UDI-DI 10195594882273 7 10195594712938(6) Cat. SAN1FPMULM - Lot #929016, Exp. 6/1/2024, UDI-DI 10195594712938 8 10195594553562(7) Cat. SAN11OADMM - Lot #985859, Exp. 11/1/2025, UDI-DI 10195594553562 9 10888439914443(8) Cat. SAN13DILCO - Lot #936019, Exp. 8/1/2024, UDI-DI 10888439914443 10 10197106209561(9) Cat. SAN13DILC6 - Lot #22275, Exp. 5/1/2024, UDI-DI 10197106209561 11 10888439936100(10) Cat. SAN21AO62F - Lot #901120, Exp. 8/1/2024, UDI-DI 10888439936100 12 10195594574918(11) Cat. SAN21APJCD - Lot #922242, Exp. 8/1/2024, UDI-DI 10195594574918 13 10888439936018(12) Cat. SAN21IP62I - Lot #917437, Exp. 6/1/2024, UDI-DI 10888439936018 14 10195594885915(13) Cat. SAN23CMCW5 - Lot #919954, Exp. 7/1/2024, UDI-DI 10195594885915 15 10888439917291(14) Cat. SAN29PCCCL - Lot #999073, Exp. 6/1/2027, UDI-DI 10888439917291 16 10888439964530(15) Cat. SAN3BPDKOC - Lot #942109, Exp. 1/1/2024, UDI-DI 10888439964530 17 10195594863579(16) Cat. SAN3BPDK12 - Lot #914221, Exp. 1/1/2024, UDI-DI 10195594863579 18 10888439973334(17) Cat. SAN30ANTHD - Lot #16600, Exp. 7/1/2025, UDI-DI 10888439973334 19 10195594119409(18) Cat. SAN30PPVGA - Lot #922151, Exp. 5/1/2025, UDI-DI 10195594119409 20 10888439903881(19) Cat. SAN32IPJWA - Lot #986373, Exp. 4/1/2024, UDI-DI 10888439903881 - Amount recalled
- 13,351 total packs
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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