FDAFDA · Food and drugs·Recall number Z-1071-2013
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.
Published April 17, 2013 · Recall initiated: October 31, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- J T Posey Company
- Distributor
- Nationwide Distribution
- Lot
- The model/catalog number for the device is 2900. All lots are being recalled.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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