Reported Apr 17, 2013 · Terminated
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent…
J T Posey Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: J T Posey Company · 5635 Peck Rd · Arcadia, CA · 91006-5851
Is this the product you have?
- 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.
- Lot codes and dates
- The model/catalog number for the device is 2900. All lots are being recalled.
- Amount recalled
- 1673 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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