Bard Catheter Repair Kits Recalled for Hardened, Unusable Adhesive
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
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 injuries or hospitalizations. The defect—hardened adhesive rendering kits unusable—presents a potential risk to patients dependent on proper catheter repairs, meeting the 'risk-of-harm product without reported injury' criterion.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling multiple catheter repair kits used with Broviac and Hickman central venous catheters. The recall includes 13 catalog numbers ranging from 2.7F to 12.5F in size, distributed in the United States and internationally (Australia, Belgium, Canada, Hong Kong, and Japan).
The adhesive contained within these repair kits may become hardened or coagulated, rendering the kits unusable for their intended repair purpose. This defect prevents the kits from functioning as designed.
Approximately 7,520 units have been distributed globally (3,764 in the U.S. and 3,243 internationally). The FDA has identified specific lot numbers and catalog numbers associated with this recall. Healthcare providers should verify their stock against the affected lot numbers provided in the official FDA notice.
Healthcare providers with affected kits should discontinue use immediately and contact Bard Peripheral Vascular Inc. for information on replacement or refund options. Patients and caregivers should consult their healthcare provider regarding their central venous catheters and should not use affected repair kits.
The recalled product
- Product
- Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all…
- Manufacturer
- Bard Peripheral Vascular Inc
Distribution
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