Recall Z-2212-2016
Carefusion 2200 Inc · initiated July 1, 2016
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
Reason for recall
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
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-2212-2016
- Initiated
- July 1, 2016
- Posted by FDA
- July 22, 2016
- Terminated
- March 29, 2017
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 10
- Distribution
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
- Recalling firm
- Carefusion 2200 Inc, Vernon Hills, IL