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

Recall Z-1422-2014 — Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems

U.S. FDA — Device Enforcement · United States · 2014-03-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1422-2014
Date of alert
2014-03-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aspen Surgical Products, Inc.
Product category
device
Product type
Devices
Reported risk: The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
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.

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