Z-0027-05

Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch

Name: Z-0027-05 Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Creator: Bioteque America Inc
Published: 2005-02-24
License: https://open.fda.gov/license/

Bioteque America Inc / initiated 2005-02-24 / Terminated

FDA source

Bioteque America Inc began a recall of Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch on 2005-02-24. The reason FDA records is "product is marketed without a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0027-05
Status: Terminated
Initiated: 2005-02-24
Posted: 2005-03-23
Terminated: 2005-06-14
Recalling firm: Bioteque America Inc
Product: Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Reason for recall: product is marketed without a 510(k)
FDA root cause: Other
Action: The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.
Quantity in commerce: 115 units
Distribution: The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.
Product codes and lots: Lot number 741105 exp 11/07

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)