—#119863

Product

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

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2013-07-16
Posted by FDA: 2013-08-20
Terminated: 2014-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.