Recall Z-2377-2019— Bard Peripheral Vascular Inc

Name: FDA recall Z-2377-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2019-05-31, terminated 2022-05-17. It names one FDA 510(k) clearance: K090101. Product: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836. Reason: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-31
Terminated: 2022-05-17
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K090101 — EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERSC.R. Bard, Inc.·cleared 2009-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836

Reason for recall

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.