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

Recall Z-1051-2014 — CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

U.S. FDA — Device Enforcement · United States · 2013-08-14 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1051-2014
Date of alert
2013-08-14
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medline Industries, Inc.
Product category
device
Product type
Devices
Reported risk: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
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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