Z-1071-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2013
- Initiation Date
- October 31, 2012
- Termination Date
- July 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1673 units
Product Description
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
Reason for Recall
The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
Distribution Pattern
Nationwide Distribution
Code Information
The model/catalog number for the device is 2900. All lots are being recalled.