FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
- Recall number
- Z-1795-2020
- Recalling firm
- Becton Dickinson & Company
- Product
- CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
- Status
- Terminated
- Initiated
- 2020-03-26
- Posted
- not on file
- Terminated
- 2020-08-21
- Reason
- The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
- Root cause
- Mixed-up of materials/components
- Action
- On March 26, 2020, an Urgent Medical Device Recall Notification was sent to consignees stating that Lot #0001304986 of the Safe-T-Centesis 8 Fr Catheter Drainage Trays shipped between June 27, 2019 and September 6, 2019 should be discarded. In addition, they were instructed to complete the Customer Response form regardless of whether or not they have any of the product. Customers with discarded product were instructed to indicate the number of affected products that were discarded on the response form and replacements would be issued to those customers.
- Quantity
- 900
- Distribution
- Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.
- Lot, serial or model codes
- Lot Number: 0001304986
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCB
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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