Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath
Bard Peripheral Vascular Inc is recalling 400 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.
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 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 400 units of the Equistream XK Long-Term Hemodialysis Catheter (REF/UDI: 5913190/(01)00801741013836; 16F). The recall is due to the presence of an incorrect peel-apart introducer sheath in the product kit.
The affected products were distributed to 67 consignees across 24 U.S. 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 facilities and consumers 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:5913190/(01)00801741013836; 16F
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 400
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)
- RECT0999
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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