Medical Device Recall: Z-0019-05

FDA Recalls dataset · Firm: Health Directions, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-04-08 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-05.

Recall Res Number
Z-0019-05
Recalling Firm / Manufacturer
Health Directions, Inc
FEI Number
2529026
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-04-08
Date Posted
2004-10-14
Date Terminated
2004-10-14
Product Code
JXK
Event Number
28852
Product Quantity
3475 units
Product Description HealthPax (HP-1). Cranial Electrotherapy Stimulator
Reason for Recall Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
Action Details The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.
Distribution Pattern The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.
Code Information / Serial Numbers HealthPax (HP-1)

Related Establishments / Registrations

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