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U.S. Department of Health and Human Services

Class 2 Device Recall Posey Connecting Straps & Belts/Locking Cuffs.

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 Class 2 Recall
Posey Connecting Straps & Belts/Locking Cuffs.
see related information
Date Posted February 03, 2009
Recall Status1 Open
Recall Number Z-0934-2009
Recall Event ID 50134
Product Classification Restraint, Protective - Product Code FMQ
Product Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.
Code Information Catalog Numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213.
Recalling Firm/
Manufacturer
J T Posey Company
5635 Peck Rd
Arcadia, California 91006
Manufacturer Reason
for Recall
The recall was initiated after an investigation conducted by the Posey Company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. In some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action An "Urgent Medical Device Recall (Correction)" letter dated August 15, 2008 was mailed via US Postal Service to affected customers. The letter described the issue, instructed customers to secure a replacement label with the correct application technique over the picture in the 2008 Posey Catalog and provided a corrected Posey Locking Cuffs Instruction Sheet (19273). The Posey Company also provided updated literature for the Posey Locking and Non-Locking Connecting Straps 19270 and 19254. The Posey Company asked customers to complete and return the "Reply Fax-Back Acknowledgment" Form via fax (626-443-5418) or e-mail (vcimmarusti@posey.com) within 7 days. Contact your Sales Representative with any questions or concerns.
Quantity in Commerce 51,200 (Approximately)
Distribution Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.
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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