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Terminated

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 Recall Z-1812-2009 · Posted 2009-08-18

Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeLIO
Date Initiated2009-05-07
Date Terminated2010-01-15
Product Quantity103 packages

Reason for Recall

Incorrect expiration date on the product

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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