Merit Medical Systems, Inc. Recall 88352
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
Merit Medical Systems, Inc. Recall 88352 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2243-2021 |
| Event ID | 88352 |
| Event 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 |
| Product Type | Devices |
| 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. |
| Quantity | 373 UNITS |
| Recall Reason | There is a potential that a package sheath contains an incorrect dilator. |
| Device Classification | 20210818 |
| Device Code Info | Lot # H2069291 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210721 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
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