| | Class 2 Device Recall Cardinal Health Presource Kits |  |
| Date Initiated by Firm | November 08, 2024 |
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| Date Posted | February 10, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1130-2025 |
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| Recall Event ID |
95947 |
| Product Classification |
General purpose dental tray - Product Code OFX
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| 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 |
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| Code Information |
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 ;
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Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
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| For Additional Information Contact | Cardinal Health Quality Systems
800-292-9332 |
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Manufacturer Reason
for Recall | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| Action | 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. |
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| Quantity in Commerce | 973,785 total units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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