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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of tissue or organ damage, but the source text describes a 'potential risk' and does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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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