FDA Medical Device Recalls (openFDA)
Deltec, Inc: Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107
- Recall number
- Z-1068-03
- Recalling firm
- Deltec, Inc
- Product
- Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107
- Status
- Terminated
- Initiated
- 2003-07-08
- Posted
- 2003-07-30
- Terminated
- 2004-07-02
- Reason
- Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
- Root cause
- Other
- Action
- A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.
- Quantity
- not on file
- Distribution
- The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
- Lot, serial or model codes
- Lot numbers M20691, 95311
- 510(k) numbers
- ["K904334"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2183502
- Firm city
- St Paul
- Firm state
- MN
- 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