Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2266-2009

Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a...

J. T. Posey Co. / initiated 2009-04-20 / Terminated / root cause: manufacturing process

J T Posey Company began a recall of Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a patient's movement to the extent necessary for... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2266-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
J. T. Posey Co.
Product
Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Product code
FMQ Restraint, Protective
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.
Root cause tag
manufacturing process
FDA 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 in commerce
186
Distribution
Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
Product codes and lots
All Product with Catalog Number 2792 manufactured between Ferbruary 2009 and April 2009.