Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395
FDA device recall Z-2335-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Integra Pain Management
- Reason for recall
- Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LZC
- Quantity affected
- 140 boxes
- Distribution
- AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.
- Date initiated
- 2008-07-07
- Date posted
- 2008-09-20
- Date terminated
- 2008-10-29
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.