Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1112-2023 — Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827

U.S. FDA — Device Enforcement · United States · 2022-12-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1112-2023
Date of alert
2022-12-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Reported risk: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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