—#188372

Product

Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K143255
Affected lot / code info: Lot # I2059849

Why it was recalled

There is a potential that 7F sheaths are packaged as 10F sheaths.

Root cause (FDA determination)

Packaging process control

Action the firm took

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, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Merit Customer Service at response@merit.com within 10 business days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. Adverse events experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch or by phone at 1-800-332-1088. 7. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MDT | Mon-Fri.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-06-30
Terminated: 2023-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.