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

Recall Z-2232-2024 — Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Ster

U.S. FDA — Device Enforcement · United States · 2024-03-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2232-2024
Date of alert
2024-03-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10193489651683
Reported risk: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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