Recall Z-3116-2011 ยท LZC Medical Glove, Specialty
Ansell Healthcare Products LLC
MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
| Date | Aug 31, 2011 (initiated Aug 4, 2011) |
| Status | Terminated |
| Reason | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | 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. |
| Quantity | 250 cases of 10 |
| Distribution | Nationwide distribution: NC, GA, IL, MO, LA, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd., Oct 22, 2003 |