CareFusion Bipolar Forceps Recalled Due to Incomplete Instructions
CareFusion recalls 142 units of bipolar surgical forceps due to incomplete Instructions for Use lacking power supply interface and maintenance guidance found in the manufacturer's version.
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 no reported hospitalizations or injuries. The hazard—incomplete instructions for critical power supply interface and maintenance procedures—is theoretical but significant for surgical equipment where improper use could lead to device malfunction or inadequate sterilization.
Plain-English summary
CareFusion 2200 Inc is recalling 142 units of the Titanium Bayonet Insulated Irrigating Bipolar Forceps (Model F-5303) due to incomplete Instructions for Use. The IFU provided to customers by BD (Becton Dickinson) omits critical safety and operational information that is contained in the manufacturer's IFU.
The missing content includes instructions for the interface with the device power supply and detailed cleaning and maintenance procedures. These omissions could prevent users from operating the forceps safely and performing required maintenance, potentially leading to improper device function or inadequate sterilization.
The affected units are identified by UDI/DI 10885403041280 and include all lots. Distribution was nationwide and to multiple international markets including Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Korea, and Thailand.
Customers should stop using affected units and contact CareFusion 2200 Inc for the complete and correct Instructions for Use, which can also be found in the attached V. Mueller Bipolar Forcep IFU.
The recalled product
- Product
- CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 142
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 10885403041280
- 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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