CLASS II Device recall · Reported 24 Jul 2019 · FDA Enforcement Report
DeRoyal The Resource Group, Crani Pack recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal The Resource Group, Crani Pack, distributed in Oklahoma. The recall was initiated on 18 Jun 2019 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-1981-2019
- FDA event ID
- 83154
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2019
- FDA classified
- 16 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 18 Jun 2019 | Recall initiated by company | |
| 16 Jul 2019 | Classified by FDA | +28 days |
| 24 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
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
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Where it was distributed
US Distribution to: OK
Questions about this recall
Is DeRoyal The Resource Group, Crani Pack recalled?
Yes. DeRoyal Industries recalled DeRoyal The Resource Group, Crani Pack on 18 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-1981-2019.
Why was it recalled?
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
Which lots are affected?
Lot 49888830
Where was it sold?
US Distribution to: OK
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DeRoyal Industries
All 226| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | DeRoyal Children's General Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |