Recall Z-2243-2021— Merit Medical Systems, Inc.

Name: FDA recall Z-2243-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-21

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2021-07-21, terminated 2023-03-13. It names one FDA 510(k) clearance: K082063. Product: MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391. Reason: There is a potential that a package sheath contains an incorrect dilator..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-21
Terminated: 2023-03-13
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K082063 — PRELUDE SHORT SHEATH INTRODUCERMerit Medical Systems, Inc.·cleared 2008-10-15

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

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Reason for recall

There is a potential that a package sheath contains an incorrect dilator.

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