Bipolar Forceps Recall Due to Incomplete Instructions for Use
BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: FDA Class II recall with missing critical operational and maintenance instructions on a surgical device. No injuries or illnesses have been reported, but incomplete IFU for power supply interface and cleaning/maintenance represents a risk-of-harm scenario on a medical device used in sterile procedures.
Plain-English summary
Carefusion 2200 Inc is recalling the V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS (1.5MM tips, 7-3/4" overall length, REF F-1304) for incomplete Instructions for Use (IFU).
The provided IFU is missing content related to the interface with the device power supply, as well as cleaning and maintenance instructions. These omissions were identified when BD compared the supplied instructions to the manufacturer's complete IFU.
The recall affects 17 units distributed nationwide and internationally to Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand. The UDI/DI is 10885403040849 and the recall applies to all lots.
Users of this device should contact Carefusion 2200 Inc to obtain the complete Instructions for Use that includes all power supply interface and maintenance information necessary for safe operation and maintenance of the device.
The recalled product
- Product
- Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 17
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 (2)
- UDI/DI 10885403040849
- ALL LOTS
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 45 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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