—#180725

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

FDA product code: GCB — Needle, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number: 0001304986

Why it was recalled

The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.

Timeline

Recall initiated: 2020-03-26
Terminated: 2020-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.