Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 10888439676167 (each) 50888439676165 (case)
- Lot #
- J46C10 ; 2) PWV2MF105
- UDI
- 10195594004217 (each) 50195594004215 (case)
- Lot #
- J8998R ; 3) PWV2MF106
- UDI
- 10195594095994 (each) 50195594095992 (case)
- Lot #
- 5136000 ; 4) PWV2MF107
- UDI
- 10195594148065 (each) 50195594148063 (case)
- Lot #
- 5140389 ; 5) PWV2MF108
- UDI
- 10195594228941 (each) 50195594228949 (case)
- Lot #
- 5140389 ; 6) PWV2MF109
- UDI
- 10195594394875 (each) 50195594394873 (case)
- Lot #
- J65K18 ; 7) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- HP1027 ; 8) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J4220A ; 9) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J43W15 ; 10) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J4953C ; 11) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J6022K ; 12) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J6372Z ; 13) PWV2MF10V
- UDI
- 10888439342741 (each) 50888439342749 (case)
- Lot #
- J7708T ; 14) PWV2MF10W
- UDI
- 10888439693645 (each) 50888439693643 (case)
- Lot #
- J8241D ; 15) PWV2MF10Y
- UDI
- 10888439967432 (each) 50888439967430 (case)
- Lot #
- J84K11 ; 16) PWV2MF10Y
- UDI
- 10888439967432 (each) 50888439967430 (case)
- Lot #
- J84K10 ; 17) PWV2MF10Z
- UDI
- 10195594180294 (each) 50195594180292 (case)
- Lot #
- J65K19 ; 18) PWV2MF10Z
- UDI
- 10195594180294 (each) 50195594180292 (case)
- Lot #
- 5775812 ; 19) PWV2MF10Z
- UDI
- 10195594180294 (each) 50195594180292 (case)
- Lot #
- 6116189 ; 20) PWV2MF10Z
- UDI
- 10195594180294 (each) 50195594180292 (case)
- Lot #
- 6251076 ; 21) PWV2MF111
- UDI
- 10195594634957 (each) 50195594634955 (case)
- Lot #
- 5858469 ; 22) PWV2MF112
- UDI
- 10195594711177 (each) 50195594711175 (case)
- Lot #
- 6022146 ; 23) PWV2MFCP2
- UDI
- 10197106368718 (each) 50197106368716 (case)
- Lot #
- 6788690 ; 24) PWV2MFCP3
- UDI
- 10197106738399 (each) 50197106738397 (case)
- Lot #
- 7333448 ; 25) PWV2MFCP4
- UDI
- 10197106784167 (each) 50197106784165 (case)
- Lot #
- 7360541 ; 26) PWV2MFCPA
- UDI
- 10197106143469 (each) 50197106143467 (case)
- Lot #
- 6701855 ; 27) PWV2MFCPB
- UDI
- 10197106245491 (each) 50197106245499 (case)
- Lot #
- 6702040 ; 28) PWV2MFCPB
- UDI
- 10197106245491 (each) 50197106245499 (case)
- Lot #
- 6788692 ; 29) PWV2MFCPC
- UDI
- 10197106425701 (each) 50197106425709 (case)
- Lot #
- 6788692 ; 30) PWV2MFCPD
- UDI
- 10197106484340 (each) 50197106484348 (case)
- Lot #
- 7160517 ; 31) PWV2MFCPD
- UDI
- 10197106484340 (each) 50197106484348 (case)
- Lot #
- 7160540 ; 32) PWV2MFCPE
- UDI
- 10197106532461 (each) 50197106532469 (case)
- Lot #
- 7287574 ; 33) PWV2MFCPF
- UDI
- 10197106548059 (each) 50197106548057 (case)
- Lot #
- 7287574 ; 34) PWV2MFCPF
- UDI
- 10197106548059 (each) 50197106548057 (case)
- Lot #
- 7287577 ; 35) PWV2MFCPF
- UDI
- 10197106548059 (each) 50197106548057 (case)
- Lot #
- 7331480
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What the firm 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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1130-2025
- FDA device classification · OFXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.6640The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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