FDA Medical Device Recalls (openFDA)
Catheter Research, Inc: 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.
- Recall number
- Z-1077-06
- Recalling firm
- Catheter Research, Inc
- 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.
- Status
- Terminated
- Initiated
- 2006-04-24
- Posted
- 2006-06-01
- Terminated
- 2007-12-04
- Reason
- The uterine stop component was not included with the device.
- Root cause
- Other
- Action
- Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.
- Quantity
- 660
- Distribution
- Minnesota and Spain.
- Lot, serial or model codes
- Lot M20772.
- 510(k) numbers
- ["K020292"]
- PMA numbers
- not on file
- Product code
- LKF
- Firm FEI
- 3008998256
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28