FDA recall record

MST Duet Reusable Handle for Single Use Heads Reusable Handle for Single Use Heads recall — FDA Z-0521-2025

Due to pin coming off of handles.

Class IIclassification
Z-0521-2025official record ID
Dec 4, 2024report date

Recall record at a glance

Official recordZ-0521-2025
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmMicroSurgical Technology Inc.
Report dateDec 4, 2024
Recall initiation dateSep 17, 2024
Quantity24
LocationRedmond, WA, United States

Official product description

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.

Why the product was recalled

Due to pin coming off of handles.

Distribution information

U.S.: CT, GA, MN, MT and TX. O.U.S.: Netherlands 24 total devices = 6 devices distributed in the United States and 18 devices distributed in Germany.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

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About this record

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