FDA recall Z-1130-2025

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 N

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-11-08

Report date

2025-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2025