Z-2243-2021 Class II Terminated
FDA device recall Z-2243-2021 was initiated by Merit Medical Systems, Inc. on July 21, 2021 and is designated Class II. Reason for recall: There is a potential that a package sheath contains an incorrect dilator. The recall status is terminated (terminated March 13, 2023). Affected quantity: 373 UNITS.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 21, 2021
- Termination Date
- March 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 373 UNITS
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.
Code Information
Lot # H2069291