The Recall Desk
HighFDA (Devices)·Z-1604-2020·Announced 2020-04-08

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.

What this means for you

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
Category
Medical Device — Patient Restraints
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

Distributed in 4 states:

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