Guidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly
Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.
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: This is an FDA Class II recall involving a manufacturing defect in a medical device component. No injuries or illnesses have been reported. However, the defect creates a risk-of-harm scenario where injury could occur if the device is inserted incorrectly due to the reversed assembly. Per the rubric, this qualifies as High severity due to being a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling Guidewire 70cm x 1mm (0.038"), catalog number 5583705. These guidewires are accessories used with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. A total of 625 units have been identified in the recall.
The guidewires were manufactured with incorrect assembly. Specifically, the proximal (stiff) end of the guidewire is located at the distal end of the hoop, reversing where it should be positioned. This positioning error creates a risk of injury if the user attempts to insert the guidewire using the proximal end.
The affected units were distributed worldwide, including U.S. distribution in Ohio, Texas, and West Virginia, as well as internationally to Belgium, Canada, France, Italy, and the United Kingdom.
Healthcare facilities and users who have received these guidewires should stop using the affected lot numbers and contact Bard Peripheral Vascular Inc. for instructions on device return or replacement. Affected lot numbers include: REGZ2564, REFV0870, REFU4050, REFT3309, REEX1002, REEW2740, REEV0897, REDY2576, REEU1584, REER0990, and REEQ0825.
The recalled product
- Product
- Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 625
Distribution
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