Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage
Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve 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 involves a medical device defect (tip breakage) that poses a risk of harm during a procedure, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters, product code 5915240, 16F, 24cm length, UDI 00801741013904. The recall involves Lot # REDN1368 with an expiration date of 9/30/2020. The product was distributed in the United States and internationally, including Australia and Canada.
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.
Healthcare providers and patients should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions or replacement.
The recalled product
- Product
- EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
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 (1)
- Lot # REDN1368 Exp. 9/30/2020
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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