Merit Medical Systems, Inc. Recall 88315
Description: 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.
Merit Medical Systems, Inc. Recall 88315 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2238-2021 |
| Event ID | 88315 |
| Event Description | 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. |
| Product Type | Devices |
| 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 |
| Quantity | 760 units |
| Recall Reason | There is a potential that 7F sheaths are packaged as 10F sheaths. |
| Device Classification | 20210818 |
| Device Code Info | Lot #I2067768 |
| Center Classification Date | 20210810 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |