Reported Nov 13, 2024 · Ongoing
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
DeRoyal Industries 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: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
- Lot codes and dates
UDI/ DI 00749756916646 (each)50749756916641 (case):
- Lot Numberslot 59839716 exp 12/1/2025
- Amount recalled
- 160 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- OH
Why it was recalled
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
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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