Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a patient's mo
FDA device recall Z-2266-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- J T Posey Company
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FMQ
- Quantity affected
- 186
- Distribution
- Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
- Date initiated
- 2009-04-20
- Date posted
- 2009-09-22
- Date terminated
- 2012-04-11
- Location
- Arcadia, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTRAINT ACCESSORIES (K963436) | J. T. Posey Co. | 1996-11-22 |