—#143661

Product

Pilling Modular Verres Body/Obturator, Product Code 140880

FDA product code: GDM — Needle, Aspiration And Injection, Reusable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot K3

Why it was recalled

Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).

Root cause (FDA determination)

Packaging process control

Action the firm took

Teleflex sent an Medical Device Advisory Notification letter dated January 8, 2016, to all affected customers notifying them of the packaging error. Our records indicate that you have received products that are subject to this notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at recalls@teleflex.com or 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: US Distribution to the state of : UT

Timeline

Recall initiated: 2015-01-08
Posted by FDA: 2016-03-16
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.