Device product
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.
Z-1071-2013
Product summary
- Event
- Event 63622
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1673 units
- Official record key
device-enforcement:Z-1071-2013
Official wording
Reason: 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.
Code information: The model/catalog number for the device is 2900. All lots are being recalled.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.