Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defect
Bard Peripheral Vascular Inc is recalling 13 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be 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 involves a risk-of-harm product (medical device defect) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 13 units of Equistream Long-Term Hemodialysis Catheters with Preloaded Stylet (REF/Product code: 5903310, 14.5F, Straight, 31cm length). The affected units are identified by Lot # REDN2376 with an expiration date of 9/30/2020.
The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. The agency has classified this as a Class II recall.
The affected units were distributed across numerous US states and territories, as well as Australia and Canada. Healthcare providers and patients should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions.
The recalled product
- Product
- EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 13
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 # REDN2376 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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