Recall Z-1521-2014 ยท KXG Applicator, Absorbent Tipped, Sterile
Fisher Scientific Co
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces
| Date | Apr 28, 2014 (initiated Feb 5, 2014) |
| Status | Terminated |
| Reason | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. |
| Root cause | Process control |
| Action | Fisher Scientific sent an Urgent: Medical Device Recall/Return letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE USER OR DISTRIBUTOR: Fisher Scientific requests that you discontinue use and distribution of all products referenced above. We also request that you return all product (opened and unopened) as soon as possible. A credit will be issued for returned product. User: Fisher Scientific requests that you complete the Acknowledgment Form enclosed with this l |
| Quantity | 7430 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.