Recalls / —
—#82255
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.
- FDA product code
- LIO — Device, Specimen Collection
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot 725080, Exp. 2013.05.28
Why it was recalled
Incorrect expiration date on the product
Root cause (FDA determination)
Incorrect or no expiration date
Action the firm took
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.
Recalling firm
- Firm
- Remel, Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2009-05-07
- Posted by FDA
- 2009-08-18
- Terminated
- 2010-01-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #82255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.