RecallRadar

FDA Device recall Z-1987-2013

PleuraGuide Disposable Chest Tube Kit

On 2013-08-28 the FDA classified a Class II recall of PleuraGuide Disposable Chest Tube Kit by Atrium Medical, citing individual component's IFUs are not included with the kit.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1987-2013
ClassificationClass II
Statusterminated
Initiated2013-07-16
Published2013-08-28
Last updated2026-09-13 11:53 UTC
CompanyAtrium Medical
DistributionUS

Product

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

Reason

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

Identifiers

code_info
Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1987-2013%22

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