Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage
Bard Peripheral Vascular Inc is recalling Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device that can cause injury during a procedure, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 34 units of Equistream Long-Term Hemodialysis Catheters (REF/Product Code: 5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length). The specific lot number is RECX2893, with an expiration date of July 31, 2020. The UDI for the product is 00801741013799.
The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This defect poses a risk of injury to patients during the medical procedure.
The affected units were distributed to healthcare facilities in numerous U.S. states and territories, as well as in Australia and Canada. Healthcare providers should stop using the affected catheters and contact Bard Peripheral Vascular Inc for instructions on returning the product.
The recalled product
- Product
- EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 34
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)
- Lot # RECX2893
- Exp. 7.31.2020
Distribution
Part of a larger recall action
This product is one of 28 recalled by Bard Peripheral Vascular 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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