Reported Aug 28, 2013 · Terminated
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 5 Wentworth Dr · Hudson, NH · 03051-4929
Is this the product you have?
- PleuraGuide Disposable Chest Tube Kit
- Product codes17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 1710010734588, 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 1715010728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130 1720010728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087 - Amount recalled
- 6,516 units
Where it was sold
- Nationwide
Why it was recalled
Individual component's IFUs are not included with the kit.
This product could cause temporary or reversible health problems — stop using it.
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