Recall Z-1955-2013 ยท KXG Applicator, Absorbent Tipped, Sterile
Fisher Scientific Co
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
| Date | Aug 12, 2013 (initiated Jun 5, 2013) |
| Status | Terminated |
| Reason | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure. |
| Root cause | Material/Component Contamination |
| Action | Customers were notified by letter on June 18, 2013 and requested to discontinue use and return all affected product. The firm also asked that any additional affected customer base be contacted and notified of the recall if the lots had been further distributed. If you have any questions, contact Stericycle (reference "Event 4070") at 1-877-410-5558. |
| Quantity | 1230 |
| Distribution | Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.