—#150113

Product

Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K831931
Affected lot / code info: All lot codes

Why it was recalled

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Root cause (FDA determination)

Labeling design

Action the firm took

Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

Timeline

Recall initiated: 2016-10-26
Terminated: 2018-10-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.