Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect
Bard Peripheral Vascular Inc is recalling Equistream XK 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 structural defect in a medical device used for hemodialysis. While no specific injuries are reported in the text, the risk of device failure during a medical procedure places it in the High severity category per the rubric for risk-of-harm products.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 455 units of Equistream XK Long-Term Hemodialysis Catheters with Preloaded Stylet. The specific product code is 5913190, 16F, Straight, 19cm length, with UDI 00801741013836. The recall involves three specific lots: RECZ2628 (exp. 9/30/2020), RECX3045 (exp. 7/31/2020), and RECW1365 (exp. 4/30/2020).
The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This is classified as an FDA Class II recall.
The affected units were distributed across 49 US states, the District of Columbia, Puerto Rico, and the Virgin Islands, as well as Australia and Canada. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 455
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 (4)
- (Lot #
- Exp.) RECZ2628 9/30/2020
- RECX3045 7/31/2020
- RECW1365 4/30/2020
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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