Z-1812-2009

Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm...

Name: Z-1812-2009 Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm...
Creator: Remel, Inc
Published: 2009-05-07
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-05-07 / Terminated

FDA source

Remel, Inc began a recall of 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... on 2009-05-07. The reason FDA records is "Incorrect expiration date on the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1812-2009
Status: Terminated
Initiated: 2009-05-07
Posted: 2009-08-18
Terminated: 2010-01-15
Recalling firm: Remel Inc
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.
Product code: LIO Device, Specimen Collection
Reason for recall: Incorrect expiration date on the product
FDA 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 in commerce: 103 packages
Distribution: Nationwide Distribution
Product codes and lots: Lot 725080, Exp. 2013.05.28

Product code LIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)