Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defects
Bard Peripheral Vascular Inc is recalling 39 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or become 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 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 is classified as FDA Class II. The hazard involves a mechanical defect (tip breakage) during a medical procedure, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 39 units of Equistream Long-Term Hemodialysis Catheters with Preloaded Styte. The specific product code is 5904270, 14.5F, Straight, 27cm length, with UDI 00801741013775. The affected lot number is RECZ3014, with an expiration date of 3/31/2020.
The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This defect could potentially interfere with the proper installation of the device.
The affected units were distributed across numerous US states, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY, as well as in Australia and Canada. Healthcare facilities and patients should check their inventory and contact Bard Peripheral Vascular Inc for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 39
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 # RECZ3014 Exp. 3/31/2020
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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