Recall Z-0934-2009 ยท FMQ Restraint, Protective
J T Posey Company
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.
| Date | Feb 3, 2009 (initiated Sep 8, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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 fa |
| Quantity | 51,200 (Approximately) |
| Distribution | Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963413 | MULTIPLE LIMB HOLDERS J. T. Posey Co., Nov 14, 1996 |