Reported Jul 12, 2023 · Ongoing
Custom medical procedure packs labeled as
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?
Custom medical procedure packs labeled as
6 of 6 products
| Model / number | Product as published |
|---|---|
89-10640 | STANDARD OB PACK ASCENSION WI |
89-10901 | ANGIO PACK |
89-1924 | BASIN |
89-7133 | CYSTO PACK |
89-9134 | TOTAL HIP PACK |
89-9478 | EMERGENCY C-SECTION PACK |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 5074975636774000749756367745REF 89-10640, (cs), 00749756367745 (unit), Lot Numbers: 58737945 5074975638024400749756380249REF 89-10901, (cs), 00749756380249 (unit), Lot Numbers: 58820749 5074975621686400749756216869REF 89-1924, (cs), 00749756216869 (unit), Lot Numbers: 58746227 5074975673674400749756736749REF 89-7133, (cs), 00749756736749 (unit), Lot Numbers: 58789323 5074975691133200749756911337REF 89-9134, (cs), 00749756911337 (unit), Lot Numbers: 58701336 5074975692690900749756926904REF 89-9478, (cs), 00749756926904 (unit), Lot Numbers: 58738454 - Amount recalled
- 328 packs
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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