Z-1795-2020Class II

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number...

Name: Z-1795-2020 CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number...
Creator: Becton Dickinson & Company
Published: 2020-03-26
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-03-26 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17)... on 2020-03-26. FDA classified it as Class II and gives the reason as "The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1795-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-26
Posted: 2020-04-24
Terminated: 2020-08-21
Recalling firm: Becton Dickinson & Co
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
Product code: GCB Needle, Catheter
Reason for recall: The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
Root cause tag: manufacturing process
FDA 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 in commerce: 900
Distribution: Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.
Product codes and lots: Lot Number: 0001304986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1795-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1795-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-24

Product code GCB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)