Recall Z-0629-2024— Merit Medical Systems, Inc.

Name: FDA recall Z-0629-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-06

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2023-11-06. It names one FDA 510(k) clearance: K992231. Product: Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY. Reason: The sterility of microcatheter and infusion system devices cannot be guaranteed..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-06
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K992231 — FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.·cleared 1999-07-23

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

Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

Reason for recall

The sterility of microcatheter and infusion system devices cannot be guaranteed.

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