BD Recalls Diamond-Flex Retractors Due to Weld Failure Risk
BD is recalling specific Diamond-Flex Circular Retractors because a weld failure could cause wire protrusion, potentially damaging tissue or organs during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
BD, formerly CareFusion, is recalling 10 units of the Diamond-Flex Circular Retractor, Angled, 40mm 5mm (Product Code 89-6114). The affected units are identified by Lot Codes 878971, 879366, and 879404, and Date Code C16. These instruments are designed to retract or elevate organs and tissue to provide better visualization access during procedures.
The recall was initiated because BD identified a potential risk associated with a weld failure. If this failure occurs while the instrument is being articulated during a procedure, the wire could protrude through the tip of the instrument. This failure has the potential to damage tissue or organs.
The affected products were distributed worldwide, including in the United States (specifically Washington and Maryland) and Japan. Healthcare facilities and users should stop using the affected units and contact BD for further instructions.
The recalled product
- 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.
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Code 89-6114
- Lot Code(s): 878971
- 879366
- 879404
- and Date Code: C16
Distribution
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