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

FDA device recall Z-1219-2007 · posted 2007-09-08 · Terminated

Recall details

Recalling firm

Molnlycke Health Care, Inc

Reason for recall

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

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.

Root cause

Packaging process control

Status

Terminated

Quantity affected

6,000 pair

Distribution

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

Date initiated

2007-07-20

Date posted

2007-09-08

Date terminated

2010-03-17

Location

Norcross, GA