MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pie
FDA device recall Z-3117-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- Reason for recall
- Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- Action taken
- Ansell account managers were notified on August 4, 2011 to contact (by phone, fax, e-mail) their respective accounts and notify them of the recall situation. The Ansell account managers were provided with a copy of the recall notification to provide to their accounts. The recall notification includes a request that if these gloves have been further distributed to other customers, please advise them of the recall situation and have them return any outstanding stocks.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- LZC
- Quantity affected
- 122 cases of 10
- Distribution
- Nationwide distribution: NC, GA, IL, MO, LA, and PA
- Date initiated
- 2011-08-04
- Date posted
- 2011-08-31
- Date terminated
- 2012-11-27
- Location
- Dothan, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED (K032374) | Perusahaan Getah Asas Sdn. Bhd. | 2003-10-22 |