Z-1219-2007

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

Name: Z-1219-2007 Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
Creator: Molnlycke Health Care, Inc
Published: 2007-07-20
License: https://open.fda.gov/license/

Molnlycke Health Care / initiated 2007-07-20 / Terminated / root cause: packaging

FDA source

Molnlycke Health Care, Inc began a recall of Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia on 2007-07-20. The reason FDA records is "Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1219-2007
Status: Terminated
Initiated: 2007-07-20
Posted: 2007-09-08
Terminated: 2010-03-17
Recalling firm: Molnlycke Health Care
Product: Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
Reason for recall: Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.
Root cause tag: packaging
FDA 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 in commerce: 6,000 pair
Distribution: Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI
Product codes and lots: Lot #07B026, Size 8

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)