Recall Z-1987-2013
Atrium Medical Corporation · initiated July 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
Codes / 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
Reason for recall
Individual component's IFUs are not included with the kit.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1987-2013
- Initiated
- July 16, 2013
- Posted by FDA
- August 20, 2013
- Terminated
- July 15, 2014
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 6,516 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Atrium Medical Corporation, Hudson, NH