Recall Z-1812-2009
Remel, Inc · initiated May 7, 2009
Product
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.
Codes / lots: Lot 725080, Exp. 2013.05.28
Reason for recall
Incorrect expiration date on the product
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1812-2009
- Initiated
- May 7, 2009
- Posted by FDA
- August 18, 2009
- Terminated
- January 15, 2010
- Product code
- LIO – Device, Specimen Collection
- Quantity
- 103 packages
- Distribution
- Nationwide Distribution
- Recalling firm
- Remel, Inc, Lenexa, KS