Recall Z-2212-2016— Carefusion 2200 Inc
Class I · Terminated
Class I FDA medical device recall by Carefusion 2200 Inc, initiated 2016-07-01, terminated 2017-03-29. It names one FDA 510(k) clearance: K092684. 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.. 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.
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-07-01
- Terminated
- 2017-03-29
- Firm location
- Vernon Hills, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.