Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

FDA device recall Z-3190-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

7F sheath introducers labeled as 7.5F

Action taken

On 8/12/24, recall notices were mailed or emailed to customers who were asked to do the following: 1) Determine if any of the products identified in the attached Customer Response From (CRF) are within your facility. 2) Ensure that appropriate 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, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4) Post this "URGENT MEDICAL DEVICE RECALL NOTICE" on or near the affected products. Product may continue to be used once this recall notice is placed on or near them. 5) Complete and return the response form via email to response@merit.com If you have any questions concerning this communication, contact the firm's Sales Representative or Customer Service at +1 800 356 3748 | Hours: 6 am to 6 pm MST, Mon-Fri.

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

DRE

Quantity affected

1892

Distribution

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Date initiated

2024-08-12

Date posted

2024-09-20

Location

South Jordan, UT

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