Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect
Bard Peripheral Vascular Inc is recalling 2 units of Equistream XK hemodialysis catheters because the molded tip may break or be damaged during placement.
What this means for you
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/damage) 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 2 units of Equistream XK Long-Term Hemodialysis Catheters with Preloaded Stylet. The specific product code is 5913310, 16F, Straight, 31cm length, with UDI 00801741013867. The recalled lot is RECX3001 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. This defect could potentially affect the safety or efficacy of the device during use.
The affected units were distributed to healthcare facilities in 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 should stop using the affected units 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:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 2
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 # RECX3001 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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