| Class 2 Device Recall Biogel Skinsense | |
Date Initiated by Firm | July 20, 2007 |
Date Posted | September 08, 2007 |
Recall Status1 |
Terminated 3 on March 17, 2010 |
Recall Number | Z-1219-2007 |
Recall Event ID |
39362 |
Product | Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia |
Code Information |
Lot #07B026, Size 8 |
Recalling Firm/ Manufacturer |
Molnlycke Health Care, Inc 5550 Peachtree Pkwy Ste 500 Norcross GA 30092-2555
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For Additional Information Contact | Steven Dowdley 678-451-8062 |
Manufacturer Reason for Recall | Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly. |
FDA Determined Cause 2 | 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 in Commerce | 6,000 pair |
Distribution | Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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