Z-1130-2025Class II

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2)...

Name: Z-1130-2025 Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2)...
Creator: Cardinal Health 200, LLC
Published: 2024-11-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-11-08 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3)... on 2024-11-08. FDA classified it as Class II and gives the reason as "Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1130-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-08
Posted: 2025-02-10
Recalling firm: Medtronic, Inc.
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
Product code: OFX General Purpose Dental Tray
Reason for recall: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
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.
Quantity in commerce: 973,785 total units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Product codes and lots: 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 ;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1127-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1128-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1129-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1130-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1131-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1132-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1133-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1134-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1135-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1136-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10
Z-1137-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-10

Product code OFX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)