Z-1987-2013Class II

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

Name: Z-1987-2013 PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the...
Creator: Atrium Medical Corporation
Published: 2013-07-16
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2013-07-16 / Terminated / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters on 2013-07-16. FDA classified it as Class II and gives the reason as "Individual component's IFUs are not included with the kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1987-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-08-20
Terminated: 2014-07-15
Recalling firm: Atrium Medical Corporation
Product: PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Individual component's IFUs are not included with the kit.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 6,516 units
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1987-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1987-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

Product code KDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)