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Terminated

PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.

FDA Recall Z-1987-2013 · Posted 2013-08-20

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeKDQ
Date Initiated2013-07-16
Date Terminated2014-07-15
Product Quantity6,516 units

Reason for Recall

Individual component's IFUs are not included with the kit.

Firm Action

Notice of correction was sent on July 18, 2013 via UPS and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. It provides instructions how to handle the product that may be affected. Additional labeling will be added to the kit to include instructions for use for the additional components. Atrium Medical will confirm through tracking of the UPS letters that each consignee has received the letter of correction. This shall be 100%. Where a UPS delivery cannot be confirmed, Atrium Medical will make good faith effort to contact the consignee to ensure that the letter was received.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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