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Terminated

Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia

FDA Recall Z-1219-2007 · Posted 2007-09-08

Recalling FirmMolnlycke Health Care, Inc
Recall StatusTerminated
Date Initiated2007-07-20
Date Terminated2010-03-17
Product Quantity6,000 pair

Reason for Recall

Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.

Firm Action

Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.

Root Cause

Packaging process control

Distribution Pattern

Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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