RecallDepth

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

Company
Molnlycke Health Care, Inc
Recall Initiated
July 20, 2007
Posted
September 8, 2007
Terminated
March 17, 2010
Recall Number
Z-1219-2007
Quantity
6,000 pair
Firm Location
Norcross, GA

Reason for Recall

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

Distribution

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

Lot / Code Info

Lot #07B026, Size 8

Root Cause

Packaging process control

Action Taken

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.

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