Reported Jan 18, 2023 · Ongoing

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

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?

  • HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Lot codes and dates
  • Assembly Number HCT3548-2
  • UDI-DIM752HCT354821
  • Lot Numbers
    • 222770947
    • 221809694
    • 221938965
    • 221748547
    • 221578546
    • 221808445
    • 221386002
    • 222859338
    • 222940522
    • 221938972
Amount recalled
112,675 units

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

Why it was recalled

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 4:56 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.