CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report

PleuraGuide Disposable Chest Tube Kit recalled by Atrium Medical

Atrium Medical is recalling PleuraGuide Disposable Chest Tube Kit, distributed nationwide in the US. The recall was initiated on 16 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled6,516 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1987-2013
FDA event ID: 65678
Recalling firm: Atrium Medical, Hudson, NH
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2013
FDA classified: 20 Aug 2013
Reported: 28 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

16 Jul 2013	Recall initiated by company
20 Aug 2013	Classified by FDA	+35 days
28 Aug 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Atrium Medical

All 153

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Oct 2024Device	CLASS II	iCast Covered Stent, 6MMx16MMx120CM recalled by Atrium Medical	Atrium Medical	Other	Nationwide
12 Jun 2024Device	CLASS II	Advanta Vxt, 1gds, Nh, Str-sw recalled by Atrium Medical	Atrium Medical	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide