Restrictive moorings, body. Mooring, Restrictive mooring, arm. Restrictive mooring, wrist. Restrictive or supportive ties with safety buckles of Model 1070 manufactured between August 2000 and June 2001: (1) Cotton belts, with safety connectors and buckles, 18 to 72 inches, (2) Polypropylene belts with connectors (3) Connected TAT Ankle Cuff, (4) Connected TAT Wrist Cuff, (5) Locking TAT Ankle Cuff, (6) Locking TAT Ankle Cuff and Strap, (7) Locking TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, TAT WATCH, 2750, (3) 2795, (4) 2794, (5) 2793, (6) 2799, (7) 2801 의 안전성 경고

Safety alert

329

2001-11-09

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

When a strong and abrupt movement is applied to the restrictive struts, the buckle lock can open, releasing the strings and possibly allowing the patient to escape, injure or injure someone. the manufacturer has not received any injury notification involving these products until then, but failure to take immediate action to return these products can result in serious injury to the patient or others. the manufacturer initiated this correction by letter dated july 25, 2001.

Verify receipt of the letter and the corrected medical product response form dated July 25, 2001 and the JT Posey Prepaid Automated UPS Return Label. Identify and isolate all affected products in your inventory. Complete the response form and return it with any affected product to the address above using the return label. Upon return of the affected product, the manufacturer will ship replacement products to your facility at no charge. If you have distributed any of these products to customers or other locations, please provide JT Posey, by post or fax, with the name, address, telephone number, contact name, date of purchase, quantity and model number of products purchased by each consumer. For more information, contact your local representative or directly with the manufacturer at jlidikay@posey.com.