Bard Equistream Hemodialysis Catheter Recalled for Tip Damage
Bard Peripheral Vascular Inc is recalling Equistream XK 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 involves a medical device defect (tip breakage) that poses a risk of harm during a procedure, but the source text does not report 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 100 units of Equistream XK Long-Term Hemodialysis Catheters with Preloaded Stylet. The specific product code is 5913420, 16F, Straight, 42cm length, with UDI 00801741013881. The affected lots are RECX2820 (expiring 7/31/2020) and RECT2105 (expiring 1/31/2020).
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 poses a risk of injury to patients during the medical procedure.
The products were distributed in the United 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, WY) and internationally in Australia and Canada. Healthcare providers and patients should contact Bard Peripheral Vascular Inc for instructions on how to return or replace the affected devices.
The recalled product
- Product
- EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 100
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 (3)
- (Lot #
- Exp.) RECX2820 7/31/2020
- RECT2105 1/31/2020
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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