Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath
Bard Peripheral Vascular Inc is recalling 215 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a product defect without reported harm.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 215 units of the Equistream XK Long-Term Hemodialysis Catheter, reference number 5913230, UDI (01)00801741013843, size 16F, lot number RECV3572. The recall is due to the presence of an incorrect peel-apart introducer sheath in the product kit.
The affected units were distributed to 67 consignees in the United States, including Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Montana, North Carolina, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
Healthcare providers and patients should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions or a replacement.
The recalled product
- Product
- EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 215
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 RECV3572
Distribution
Part of a larger recall action
This product is one of 2 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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