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Terminated

VersaSafe Extension Set, Model No. 21000M-007

FDA Recall Z-0435-2014 · Posted 2013-12-03

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-11-08
Date Terminated2014-04-17
Product Quantity3500 units

Reason for Recall

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944320VENTED/NON-VENTED GEMINI ADMINISTRATION SETImed Corp. · 1995-02-14

Official Source

View FDA Recall →

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

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