Medical Device Recall: Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) O
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) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
States Affected
NATIONWIDE
Quantity Affected
2344 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0778-2025
Status: ongoing
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