FDA recall Z-0777-2025

Product

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.

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-11-21

Report date

2025-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2025