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U.S. Department of Health and Human Services

Class 2 Device Recall Wrist restraint, wrist cuff

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 Class 2 Recall
Wrist restraint, wrist cuff
see related information
Date Posted April 09, 2013
Recall Status1 Terminated on July 17, 2014
Recall Number Z-1071-2013
Recall Event ID 63622
Product Classification Restraint, Protective - Product Code FMQ
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.
Code Information The model/catalog number for the device is 2900. All lots are being recalled.
Recalling Firm/
Manufacturer
J T Posey Company
5635 Peck Rd
Arcadia, California 91006-5851
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Process Design
Action J. T. Posey sent an Medical Device Recall (Removal) letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customer that Posey Company is voluntarily recalling all units of Posey BiothaneQD Cuffs, Catalog Number 2900. All lots of this product are being recalled. Reason for recall was listed:"Posey has identified rivets on the 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. No patient injuries or deaths have reported." Please immediately discontinue further distribution or use of Posey Biothane~ Cuffs, Catalog Number 2900. Please Complete and return the Acknowledgement and Receipt Form to Posey within 7 days using the provided self-addressed, stamped envelope, by fax to 626-443-5418 or via e-mail to RegulatoryAffairs@Posey.com. Return this form even if you do not have any devices in your facility. Please return directly to Posey ill! units you have of Biothane~ Cuffs, Catalog Number 2900, using the enclosed pre-paid shipping label containing an RMA number. Posey will provide replacement product or credit upon receipt of the product. If you have any further questions please call (626) 443-3143.
Quantity in Commerce 1673 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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