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.
Reported: August 3, 2016 Initiated: July 1, 2016 #Z-2212-2016
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
Details
- Recalling Firm
- Carefusion 2200 Inc
- Units Affected
- 10
- Distribution
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
- Location
- Vernon Hills, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Carefusion 2200 Inc. Units affected: 10.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Critical. Recall number: Z-2212-2016.
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