Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading

FDA device recall Z-2433-2012 · posted 2012-09-21 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Action taken

Covidien issued an "URGENT MEDICAL DEVICE RECALL" letter dated August 21, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm sent a revised customer recall notification letter via FedEx overnight delivery to all customers who purchased Duet TRS" devices from August 2009- August 2012. This letter went to all customers whether they had been sent the August 21st letter or not. Users were advised that Covidien was recalling all lots of the Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU). On August 23rd 2012, Covidien notified, via e-mail, perspective surgeons that were planning to participate in the "Duet TRS Patient Registry" of the recall and that as a result the Duet TRS registry program was discontinued. Customers were asked to complete and return a Recalled Product Form via fax to (800) 895-6140. Contact Covidien Customer Service at (800) 722-8772, option 1 for questions regarding this recall.

Root cause

Device Design

Status

Terminated

Product code

GDW

Quantity affected

94,301 units

Distribution

Worldwide Distribution.

Date initiated

2012-08-21

Date posted

2012-09-21

Date terminated

2016-08-30

Location

North Haven, CT

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