Molnlycke Health Care, Inc
Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
| Date | Sep 8, 2007 (initiated Jul 20, 2007) |
| Status | Terminated |
| Reason | Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 6,000 pair |
| Distribution | Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.