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Terminated

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.

FDA Recall Z-0934-2009 · Posted 2009-02-03

Recalling FirmJ T Posey Company
Recall StatusTerminated
Product CodeFMQ
Date Initiated2008-09-08
Date Terminated2012-04-16
Product Quantity51,200 (Approximately)

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.

Firm 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 ([email protected]) within 7 days. Contact your Sales Representative with any questions or concerns.

Root Cause

Other

Distribution Pattern

Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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