Reported Jun 8, 2022 · Terminated

4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360

Busse Hospital Disposables, 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: Busse Hospital Disposables, Inc. · 75 Arkay Dr · Hauppauge, NY · 11788-3707

Is this the product you have?

  • 4.5MM Pellet Insertion
  • Tray with Large Gloves Catalog NumberB1360
Lot codes and dates
  • Lot Numbers2010336
  • UDI00849233004627
Amount recalled
30 units

This recall covers 58 products

The agency filed one notice per product. You are reading one of them; the other 57 are below.

45 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2024 · Data as of Sep 19, 4:52 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.