Bard Equistream XK Hemodialysis Catheter Recalled for Tip Damage
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for significant injury or structural defects in medical devices are categorized as Severe.
Plain-English summary
Bard Peripheral Vascular Inc is voluntarily recalling specific lots of Equistream XK Long-Term Hemodialysis Catheters with Preloaded Stylet. The recall involves 1,114 units of the 16F, Straight, 23cm length catheters (REF/Product code: 5913230). The affected lots are RECX3719, RECV3572, RECU0189, and RECT1026, with expiration dates ranging from April 30, 2020, to September 30, 2020.
The FDA classified this as a Class II recall because the action is being initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This defect could potentially lead to complications during the medical procedure.
The affected products were distributed to healthcare facilities in 48 U.S. states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada. Healthcare providers should stop using the affected lots and contact Bard Peripheral Vascular Inc for instructions on returning or replacing the devices.
The recalled product
- Product
- EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 1,114
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 (5)
- (Lot #
- Exp.) RECX3719 9/30/2020
- RECV3572 6/30/2020
- RECU0189 4/30/2020
- RECT1026 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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