CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report
Custom medical procedure packs labeled as recalled by DeRoyal Industries
DeRoyal Industries is recalling Custom medical procedure packs labeled as: a) Cath Angiography Drape Pack, distributed nationwide in the US. The recall was initiated on 30 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2090-2023
- FDA event ID
- 92445
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2023
- FDA classified
- 3 Jul 2023
- Reported
- 12 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 May 2023 | Recall initiated by company | |
| 3 Jul 2023 | Classified by FDA | +34 days |
| 12 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Which lots are affected?
a) REF 89-7102, GTIN 50749756734085 (cs), 00749756734080 (unit), Lot Numbers: 58806701; b) REF 89-7322, GTIN 50749756736171 (cs), 00749756736176 (unit), Lot Numbers: 58821231; c) REF 89-9183, GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 92445| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Custom medical procedure packs labeled as: a) Open Heart Tracecart recalled | DeRoyal Industries | Sterility | Nationwide | |
| CLASS II | Custom medical procedure packs labeled as recalled by DeRoyal Industries | DeRoyal Industries | Sterility | Nationwide | |
| CLASS II | Custom medical procedure packs labeled as: a) Pelvic Exam Tray recalled | DeRoyal Industries | Sterility | Nationwide | |
| CLASS II | Custom medical procedure packs labeled as recalled by DeRoyal Industries | DeRoyal Industries | Sterility | Nationwide |
More recalls from DeRoyal Industries
All 227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalled | DeRoyal Industries | Temperature Abuse | Nationwide |
| Device | CLASS II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled | DeRoyal Industries | Sterility | Nationwide |
| Device | CLASS II | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled | DeRoyal Industries | Foreign Material | 5 states |
| Device | CLASS II | DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries | DeRoyal Industries | Packaging Defects | 21 states |
| Device | CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |