Posey—Biothane Ankle/Wrist Restraint Cuffs: Rivets May Not Meet Tensile Strength Specifications

ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a November 12, 2012, Urgent Medical Device Recall Removal letter submitted by ECRI Institute member hospitals, Posey states that the rivets on the restraints below may not meet the required specifications for tensile strength, potentially allowing the cuff to become disconnected from the connecting strap and allowing patients to regain free use of their limbs. Posey states that it has received no reports of patient injury or death; however, this problem may pose a risk of injury to the patient or caregiver. The manufacturer has not confirmed the...