Bard Hemodialysis Catheter Recalled Due to Tip Breakage During Placement
Bard Peripheral Vascular Inc is recalling 1,356 EQUISTREAM Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.
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 with a mechanical defect that poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, 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 1,356 units of the EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styte (REF/Product code: 5903190, 14.5F, Straight, 19cm length). The affected lots are RECZ3009, RECZ0716, RECW0585, RECX1187, and RECV1624, with expiration dates ranging from January 31, 2020, to August 31, 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 product was distributed across the United States, including all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada.
Healthcare providers and patients should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions or replacement units.
The recalled product
- Product
- EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 1,356
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 #
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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