US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications fo

FDA device recall Z-1819-2012 · posted 2012-06-18 · Terminated

Recall details

Recalling firm

Non-Invasive Monitoring Systems, Inc.

Reason for recall

Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.

Action taken

NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials. For any questions customers were instructed to call 305-575-4204. For questions regarding this recall call 305-575-4201.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

IRO

Quantity affected

US-001 Rev A brochure: 3665

Distribution

Nationwide Distribution

Date initiated

2012-05-07

Date posted

2012-06-18

Date terminated

2012-07-16

Location

Miami, FL