Reported Jul 12, 2023 · Ongoing
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF…
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 asa) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 5074975673408500749756734080REF 89-7102, (cs), 00749756734080 (unit), Lot Numbers: 58806701 5074975673617100749756736176REF 89-7322, (cs), 00749756736176 (unit), Lot Numbers: 58821231 89-9183074975690484600749756904841GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944 - Amount recalled
- 306 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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