Recall Z-2212-2016 ยท GCJ Laparoscope, General & Plastic Surgery
Carefusion 2200 Inc
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.
| Date | Jul 22, 2016 (initiated Jul 1, 2016) |
| Status | Terminated |
| Reason | 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 | Material/Component Contamination |
| Action | 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 |
| Quantity | 10 |
| Distribution | Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092684 | LAPAROSCOPIC RETRACTORS Cardinal Health, Inc., Jan 22, 2010 |