FDA Device recall Z-2212-2016
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971
- FDA Device
- Class I
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class I recall of DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971 by Carefusion 2200, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2212-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-07-01 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 2200 |
| Distribution | MD, WA |
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
Identifiers
| code_info | Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2212-2016%22
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