Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
This recall has been terminated (originally issued September 8, 2007).
- 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
- Official Source
- View on FDA website ↗
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.