U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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protective restraint - Product Code FMQ
원인
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.
조치
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.
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.