FDA Medical Device Recalls (openFDA)
Integra Pain Management: 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.
- Recall number
- Z-2335-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-07-07
- Posted
- 2008-09-20
- Terminated
- 2008-10-29
- Reason
- Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
- 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
- 140 boxes
- Distribution
- AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.
- Lot, serial or model codes
- Lot No: W0806178, W0806179, and W0806177
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZC
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28