Recall Z-2275-2009 ยท FMQ Restraint, Protective
J T Posey Company
Posey Swedish Belt (1337). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
| Date | Sep 22, 2009 (initiated Apr 20, 2009) |
| Status | Terminated |
| Reason | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. |
| Root cause | Employee error |
| Action | JT Posey Company issued an "Urgent Medical Device Recall (Removal)" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form. For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111. |
| Quantity | 659 |
| Distribution | Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963436 | RESTRAINT ACCESSORIES J. T. Posey Co., Nov 22, 1996 |