Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the la
FDA device recall Z-1812-2009 · posted 2009-08-18 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Incorrect expiration date on the product
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- LIO
- Quantity affected
- 103 packages
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-05-07
- Date posted
- 2009-08-18
- Date terminated
- 2010-01-15
- Location
- Lenexa, KS
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