Recall Z-1812-2009 ยท LIO Device, Specimen Collection
Remel, Inc
Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.
| Date | Aug 18, 2009 (initiated May 7, 2009) |
| Status | Terminated |
| Reason | Incorrect expiration date on the product |
| Root cause | Incorrect or no expiration date |
| Action | The recalling firm issued Important Medical Device Product Recall Notice letters dated 5/7/09 via regular mail to their direct accounts explaining the reason for recall and requesting they discard all remaining units of the affected lot number in their inventory. A Product Inventory Checklist was enclosed to be returned in the enclosed self-addressed, stamped envelope to report the amount of product that was discarded. The Technical Services Department should be contacted at 800-447-3641 if there are any inquiries concerning the letter. |
| Quantity | 103 packages |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.