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

Recall Z-0637-2014 — Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Me

U.S. FDA — Device Enforcement · United States · 2013-11-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0637-2014
Date of alert: 2013-11-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ansell Sandel Medical Industries LLC
Product category: device
Product type: Devices

Reported risk: Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

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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