FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: VersaSafe Extension Set, Model No. 21000M-007
- Recall number
- Z-0435-2014
- Recalling firm
- CareFusion 303, Inc.
- Product
- VersaSafe Extension Set, Model No. 21000M-007
- Status
- Terminated
- Initiated
- 2013-11-08
- Posted
- 2013-12-03
- Terminated
- 2014-04-17
- Reason
- CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.
- Root cause
- Employee error
- Action
- A customer letter and a distributor letter will be distributed on 11/8/13 to all customers who purchased the VersaSafe Extension Set, Model 21000M-07, Lot Number 13066550. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card.
- Quantity
- 3500 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot No. 13066550
- 510(k) numbers
- ["K944320"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2016493
- 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