Recall Z-2243-2021 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
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
| Date | Jul 21, 2021 |
| Status | Terminated |
| Reason | There is a potential that a package sheath contains an incorrect dilator. |
| Root cause | Process control |
| Action | Merit Medical issued an "Urgent Medical Device Recall Notice" on July 12, 2021 via FedEx to all affected consignees. In addition to informing consignees about the recall, Merit Medical request consignees take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this recall. 3. If the product has been further distributed to other facilities, institutions |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082063 | PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc., Oct 15, 2008 |