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

FDA device recall Z-1987-2013 · posted 2013-08-20 · Terminated

Recall details

Recalling firm

Atrium Medical Corporation

Reason for recall

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

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

KDQ

Quantity affected

6,516 units

Distribution

Nationwide Distribution.

Date initiated

2013-07-16

Date posted

2013-08-20

Date terminated

2014-07-15

Location

Hudson, NH