Recall Z-2238-2021 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
| Date | Jun 30, 2021 |
| Status | Terminated |
| Reason | There is a potential that 7F sheaths are packaged as 10F sheaths. |
| Root cause | Packaging process control |
| Action | On June 30, 2021, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx overnight. In addition, to informing consignees about the recall, the firm ask consignees to take the following action: 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 field action. 3. If the product has been further distributed to other facilities, institu |
| Quantity | 760 units |
| Distribution | US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143255 | Prelude SNAP Splittable Sheath Introducer Merit Medical Systems, Inc., Apr 9, 2015 |