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U.S. Department of Health and Human Services

Class 2 Device Recall Biogel Skinsense

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 Class 2 Device Recall Biogel Skinsensesee related information
Date Initiated by FirmJuly 20, 2007
Date PostedSeptember 08, 2007
Recall Status1 Terminated 3 on March 17, 2010
Recall NumberZ-1219-2007
Recall Event ID 39362
ProductBiogel 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
For Additional Information ContactSteven 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
ActionConsignees 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 Commerce6,000 pair
DistributionNationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI

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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