Recall Z-2209-2020— Bard Peripheral Vascular Inc

Name: FDA recall Z-2209-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-14

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2019-06-14, terminated 2024-09-18. It names one FDA 510(k) clearance: K090901. Product: EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F. Reason: Incorrect Peel-Apart Introducer Sheath in Kit..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Terminated: 2024-09-18
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8Osmetech Molecular Diagnostics·cleared 2009-07-06

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. REF/UDI:5913190/(01)00801741013836; 16F

Reason for recall

Incorrect Peel-Apart Introducer Sheath in Kit.

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