Reported Jun 1, 2022 · Ongoing

Surgical Suture Kit

Stradis Healthcare

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: Stradis Healthcare · 3600 Burwood Dr · Waukegan, IL · 60085-8399

Is this the product you have?

  • Surgical Suture Kit
Lot codes and dates
  • Part NumberZZ-0958
  • Primary DI NumberM752ZZ09580
  • Lot Numbers
    • 213639474
    • 212957814
    • 212675717
Amount recalled
7340 units

Where it was sold

Why it was recalled

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

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, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.