Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- January 27, 2025
- Posted
- March 24, 2025
- Recall Number
- Z-1434-2025
- Quantity
- 40
- Firm Location
- Jordan, UT
Reason for Recall
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Distribution
International distribution to the country of Japan.
Lot / Code Info
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Root Cause
Packaging process control
Action Taken
On 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Questions can be directed to Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.