Z-2212-2016 Class I Terminated
FDA device recall Z-2212-2016 was initiated by Carefusion 2200 Inc on Jul 1, 2016 and is designated Class I. 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… The recall status is terminated (terminated Mar 29, 2017). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 3, 2016
- Initiation Date
- Jul 1, 2016
- Termination Date
- Mar 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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
Distribution Pattern
Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Code Information
Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2212-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026