Z-1077-06

Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or...

Name: Z-1077-06 Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or...
Creator: Catheter Research, Inc
Published: 2006-04-24
License: https://open.fda.gov/license/

Biomerics / initiated 2006-04-24 / Terminated

FDA source

Catheter Research, Inc began a recall of Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix... on 2006-04-24. The reason FDA records is "The uterine stop component was not included with the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1077-06
Status: Terminated
Initiated: 2006-04-24
Posted: 2006-06-01
Terminated: 2007-12-04
Recalling firm: Biomerics
Product: Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: The uterine stop component was not included with the device.
FDA root cause: Other
Action: Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.
Quantity in commerce: 660
Distribution: Minnesota and Spain.
Product codes and lots: Lot M20772.

Product code LKF

K020292Class IIUterine InjectorCatheter Research, Inc. / cleared 2002-04-17

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)