Cardinal Health Presource Kits recallZ-1130-2025 · Cardinal Health 200, LLC · initiated Nov 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
FDA root cause category: Material/Component Contamination
What the company is doing
An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Recall details
- Recall number
- Z-1130-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 8, 2024
- Posted by the FDA
- Feb 10, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 973,785 total units
- Product code
- OFX
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Product description
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6022K ; 12) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6372Z ; 13) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J7708T ; 14) PWV2MF10W, UDI-DI:10888439693645 (each) 50888439693643 (case), Lot Number: J8241D ; 15) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K11 ; 16) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K10 ; 17) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: J65K19 ; 18) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 5775812 ; 19) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6116189 ; 20) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6251076 ; 21) PWV2MF111, UDI-DI:10195594634957 (each) 50195594634955 (case), Lot Number: 5858469 ; 22) PWV2MF112, UDI-DI:10195594711177 (each) 50195594711175 (case), Lot Number: 6022146 ; 23) PWV2MFCP2, UDI-DI:10197106368718 (each) 50197106368716 (case), Lot Number: 6788690 ; 24) PWV2MFCP3, UDI-DI:10197106738399 (each) 50197106738397 (case), Lot Number: 7333448 ; 25) PWV2MFCP4, UDI-DI:10197106784167 (each) 50197106784165 (case), Lot Number: 7360541 ; 26) PWV2MFCPA, UDI-DI:10197106143469 (each) 50197106143467 (case), Lot Number: 6701855 ; 27) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6702040 ; 28) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6788692 ; 29) PWV2MFCPC, UDI-DI:10197106425701 (each) 50197106425709 (case), Lot Number: 6788692 ; 30) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160517 ; 31) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160540 ; 32) PWV2MFCPE, UDI-DI:10197106532461 (each) 50197106532469 (case), Lot Number: 7287574 ; 33) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287574 ; 34) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287577 ; 35) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7331480 ;
Devices named in this recall
21 devices in the FDA device registry whose identifier appears in the recall's code information.
- CARDINAL HEALTH PWV2MF105Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF106Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF107Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF10ZCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF108Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF109Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF111Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF112Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPACardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPBCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCP2Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPCCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPDCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPECardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCPFCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCP3Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MFCP4Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF10VCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF104Cardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF10WCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
- CARDINAL HEALTH PWV2MF10YCardinal Health 200, LLC · General purpose dental tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95947).
- Z-1126-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP …
- Z-1127-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Cat…
- Z-1128-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4…
- Z-1129-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Ca…
- Z-1131-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
- Z-1132-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FA…
- Z-1133-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Nu…
- Z-1134-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catal…
- Z-1135-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number…
- Z-1136-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR…
- Z-1137-2025 · Open, ClassifiedCardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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