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
Reported: August 18, 2021 Initiated: July 21, 2021 #Z-2243-2021
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 373 UNITS
- Distribution
- 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.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Merit Medical Systems, Inc.. Units affected: 373 UNITS.
Why was this product recalled? ▼
There is a potential that a package sheath contains an incorrect dilator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2243-2021.
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