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
22 of 22 products
| # | Product as published |
|---|---|
| 1 | OPEN HEART TRACECART, REF '53-1941 |
| 2 | CARDIAC CATH PACK, REF '89-10045 |
| 3 | SHOULDER PACK, REF '89-10115 |
| 4 | MINOR ORTHO PACK, REF '89-10213 |
| 5 | TOTAL KNEE PACK PGYBK, REF '89-10505 |
| 6 | ANTERIOR HIP PACK PGYBK, REF '89-10563 |
| 7 | ORTHO X-RAY PACK, REF '89-1495 |
| 8 | GU PACK, REF '89-4479 |
| 9 | BREAST PACK, REF '89-5424 |
| 10 | SHOULDER ARTHROSCOPY PK, REF '89-6606 |
| 11 | GYN PACK, REF '89-7369 |
| 12 | ENT PACK, REF '89-7378 |
| 13 | TOTAL HIP PACK PGYBK, REF '89-7540 |
| 14 | EPIDURAL TRAY/CUSTOM, REF '89-8061 |
| 15 | BREAST BIOPSY TRAY, REF '89-8187 |
| 16 | BEACH CHAIR PACK, REF '89-8439 |
| 17 | TOTAL KNEE PACK PGYBK, REF '89-8445 |
| 18 | CYSTO PACK, REF '89-8482 |
| 19 | SINGLE BASIN PLUS, REF '89-9131 |
| 20 | TOTAL HIP PACK, REF '89-9287 |
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published 5074975686467600749756864671REF '53-1941, (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383 5074975698012300749756980128REF '89-10045, (cs), 00749756980128 (unit), Lot Numbers: 58714313 5074975697790100749756980128REF '89-10115, (cs), 00749756980128 (unit), Lot Numbers: 58746278 5074975635013100749756350136REF '89-10213, (cs), 00749756350136 (unit), Lot Numbers: 58745371 5074975636312400749756363129REF '89-10505, (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885 5074975636398800749756363983REF '89-10563, (cs), 00749756363983 (unit), Lot Numbers: 58800174 5074975621473000749756214735REF '89-1495, (cs), 00749756214735 (unit), Lot Numbers: 58762104 5074975659152700749756591522REF '89-4479, (cs), 00749756591522 (unit), Lot Numbers: 58810330 5074975663673000749756636735REF '89-5424, (cs), 00749756636735 (unit), , Lot Numbers: 58698974 5074975668642100749756686426REF '89-6606, (cs), 00749756686426 (unit), , Lot Numbers: 58698907 5074975673669000749756736695REF '89-7369, (cs), 00749756736695 (unit), , Lot Numbers: 58777761 5074975673640900749756736404REF '89-7378, (cs), 00749756736404 (unit), , Lot Numbers: 58811834 5074975674141000749756741415REF '89-7540, (cs), 00749756741415 (unit), Lot Numbers: 58737081 5074975680729100749756807296REF '89-8061, (cs), 00749756807296 (unit), Lot Numbers: 58698042 5074975681848800749756818483REF '89-8187, (cs), 00749756818483 (unit), Lot Numbers: 58736862 5074975683692500749756836920REF '89-8439, (cs), 00749756836920 (unit), Lot Numbers: 58823595 5074975684009000749756840095REF '89-8445, (cs), 00749756840095 (unit), , Lot Numbers: 58697963 5074975684833100749756848336REF '89-8482, (cs), 00749756848336 (unit), Lot Numbers: 58789411 5074975694503000749756945035REF '89-9131, (cs), 00749756945035 (unit), , Lot Numbers: 58808416 5074975693800100749756938006REF '89-9287, (cs), 00749756938006 (unit), , Lot Numbers 58789260 - Amount recalled
- 4225 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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