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

Recall Z-2447-2012 — Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL

U.S. FDA — Device Enforcement · United States · 2012-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2447-2012
Date of alert: 2012-08-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Applied Medical Resources Corp
Product category: device
Product type: Devices

Reported risk: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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