FDA Medical Device Recalls (openFDA)
Venetec Intl Inc: StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
- Recall number
- Z-0925-03
- Recalling firm
- Venetec Intl Inc
- Product
- StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
- Status
- Terminated
- Initiated
- 2003-05-12
- Posted
- 2003-06-12
- Terminated
- 2003-10-14
- Reason
- Set tubing disconnected from the male luer lock during use on patients. Misassembled.
- Root cause
- Other
- Action
- A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
- Quantity
- 3150 units
- Distribution
- One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
- Lot, serial or model codes
- Lot D207201
- 510(k) numbers
- ["K980992"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1000117366
- Firm city
- San Diego
- Firm state
- CA
- 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