Reported Dec 4, 2024 · Ongoing

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps…

MicroSurgical Technology Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MicroSurgical Technology Inc · 8415 154th Ave Ne · Redmond, WA · 98052-6482

Is this the product you have?

  • Brand NameMST Duet Reusable Handle
  • for Single Use Heads Product NameReusable Handle for Single Use Heads (Forceps
  • and Scissors) Model/Catalog NumberDFH-1028
  • Software VersionN/A
  • Product DescriptionA 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
  • ComponentYes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads
Lot codes and dates
  • Lot CodeProduct
  • CodesHNF or HNR (Regulation Number 886.4350). Either code can apply as the Duet Handle Assembly can be used with MST Duet Ophthalmic Scissors or MST Duet Forceps
  • UDI00844685005536 Lot #: 160458. Lot number is a sequential number generated through the internal SAP. All finished goods can be effectively traced by the lot number as either the finished good part or the sub part used
  • Expected lifeThe number of handle reprocessing cycles is not limited as long as the post-cleaning and pre-use inspections determine that the product is still functional and shows no signs of damage or corrosion
Amount recalled
24

Where it was sold

Why it was recalled

Due to pin coming off of handles.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

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