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

Recall Z-1751-2013 — LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hos

U.S. FDA — Device Enforcement · United States · 2013-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1751-2013
Date of alert: 2013-06-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hospira Inc.
Product category: device
Product type: Devices

Reported risk: Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.

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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