DeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect
DeRoyal is recalling 108 custom surgical packs in Oklahoma because they contain defective Cardinal Health Blunt Cannulas that could compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (compromised sterility barrier) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DeRoyal Industries Inc is recalling 108 units of DeRoyal THE RESOURCE GROUP CRANI PACK custom surgical packs (REF 89-9211.07, Lot 49888830). The recall is limited to distribution in Oklahoma.
The recall was initiated because the surgical packs contain Cardinal Health Blunt Cannulas that were previously recalled due to a manufacturing defect in the cartridge component. This defect could compromise the sterility barrier of the product.
Healthcare facilities and consumers who have these specific surgical packs should stop using them and contact DeRoyal Industries Inc for further instructions.
The recalled product
- Product
- DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 49888830
Distribution
Distributed in 1 state:
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