DeRoyal Security Cuffs Recalled for Insufficient Buckle Hold Force
DeRoyal is recalling 94 pairs of security cuffs because the buckles do not meet required mechanical hold force standards.
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 medical device used for patient restraint where the buckle fails to meet mechanical hold force requirements, creating a risk of harm if the restraint fails, but no injuries or illnesses have been reported.
Plain-English summary
DeRoyal Industries Inc is recalling 94 pairs of DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138. The recall involves one lot of product that was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
The affected product is used for patient restraint. The distribution pattern for this recall includes Virginia, California, Florida, and Arizona. The specific lot code is 50192186 and the GTIN is 0749756946865.
Healthcare facilities and consumers should stop using the affected security cuffs and contact DeRoyal Industries Inc for further instructions or a replacement.
The recalled product
- Product
- DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 94
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)
- GTIN: 0749756946865 Lot Code: 50192186
Distribution
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