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Terminated

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 Recall Z-1795-2020 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeGCB
Date Initiated2020-03-26
Date Terminated2020-08-21
Product Quantity900

Reason for Recall

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

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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