—#147639

Product

DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K092684
Affected lot / code info: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

Why it was recalled

BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.

Timeline

Recall initiated: 2016-07-01
Posted by FDA: 2016-07-22
Terminated: 2017-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.