Medical Device Recall: Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF
MEDLINE INDUSTRIES, LP - Northfield · November 21, 2024
Reason for Recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Product Description
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
States Affected
NATIONWIDE
Quantity Affected
1236 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0777-2025
Status: ongoing
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