FDAClass IIApril 17, 2013

Posey Biothane Restraint Cuffs recall

Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or…

Why was Posey Biothane Restraint Cuffs 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

The model/catalog number for the device is 2900. All lots are being recalled.

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…
Recalling firm
J T Posey Company
Quantity
1673 units
Distribution
Nationwide Distribution
Recall date
April 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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