Z-2335-2008

Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain...

Name: Z-2335-2008 Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain...
Creator: Integra Pain Management
Published: 2008-07-07
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2008-07-07 / Terminated / root cause: labeling and UDI

FDA source

Integra Pain Management began a recall of Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah... on 2008-07-07. The reason FDA records is "Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2335-2008
Status: Terminated
Initiated: 2008-07-07
Posted: 2008-09-20
Terminated: 2008-10-29
Recalling firm: Integra Pain Management
Product: Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.
Product code: LZC Medical Glove, Specialty
Reason for recall: Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210.
Quantity in commerce: 140 boxes
Distribution: AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.
Product codes and lots: Lot No: W0806178, W0806179, and W0806177

Product code LZC

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)