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

Recall Z-1906-2016 — Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)

U.S. FDA — Device Enforcement · United States · 2016-04-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1906-2016
Date of alert
2016-04-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B. Braun Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
61342856
Reported risk: BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
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.