—#211605

Product

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

FDA product code: OFX — General Purpose Dental Tray
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: 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 ;

Why it was recalled

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Timeline

Recall initiated: 2024-11-08
Posted by FDA: 2025-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211605. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.