Date Initiated by Firm |
April 20, 2009 |
Date Posted |
September 22, 2009 |
Recall Status1 |
Terminated 3 on April 11, 2012 |
Recall Number |
Z-2275-2009 |
Recall Event ID |
52711 |
510(K)Number |
K963436
|
Product Classification |
Restraint, protective - Product Code FMQ
|
Product |
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. |
Code Information |
All Product with Catalog Number 1337 manufactured between Ferbruary 2009 and April 2009. |
Recalling Firm/ Manufacturer |
J T Posey Company 5635 Peck Rd Arcadia CA 91006
|
For Additional Information Contact |
626-443-3143
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 in Commerce |
659 |
Distribution |
Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FMQ and Original Applicant = J. T. POSEY CO.
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