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

Recall Z-1660-2013 — Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheat

U.S. FDA — Device Enforcement · United States · 2012-11-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1660-2013
Date of alert: 2012-11-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merit Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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