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

Recall Z-0788-2018 — AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02

U.S. FDA — Device Enforcement · United States · 2017-06-22 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0788-2018
Date of alert
2017-06-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Avid Medical, Inc.
Product category
device
Product type
Devices
Reported risk: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
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.