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Class 2 Device Recall Radiation Reduction Gloves |
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| Date Initiated by Firm |
July 07, 2008 |
| Date Posted |
September 20, 2008 |
| Recall Status1 |
Terminated 3 on October 29, 2008 |
| Recall Number |
Z-2335-2008 |
| Recall Event ID |
48971 |
| Product Classification |
Glove, patient examination, specialty - Product Code LZC
|
| 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. |
| Code Information |
Lot No: W0806178, W0806179, and W0806177 |
Recalling Firm/
Manufacturer |
Integra Pain Management
3395 W 1820 S
Salt Lake City UT 84104-4921
|
| For Additional Information Contact |
Nola Benstog
801-886-9505
|
Manufacturer Reason
for Recall |
Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
|
FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
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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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