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Terminated

Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

FDA Recall Z-1426-2018 · Posted None

Recalling FirmCarefusion 2200 Inc
Recall StatusTerminated
Product CodeFSH
Date Initiated2017-02-23
Date Terminated2019-07-09
Product Quantity1200 units

Reason for Recall

The integrity of the sterile packaging is potentially compromised.

Firm Action

On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.

Root Cause

Package design/selection

Distribution Pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Official Source

View FDA Recall →

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

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