Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1220-04

Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter

Respironics, Inc. / initiated 2004-06-04 / Terminated

Respironics, Inc. began a recall of Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter on . The reason FDA records is "Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1220-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
Product code
BZQ Monitor, Breathing Frequency
Reason for recall
Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
FDA root cause
Other
Action
The recalling firm sent a recall letter to their direct accounts, which include parents and vendors regarding the problem associated with the battery packs. The recall letter advised their customers to check their inventory and if the battery pack is one of the affected recalled product to immediately contact their Customer Service Department. to arrange for replacement battery packs.
Quantity in commerce
2726 units
Distribution
The recalled product was distributed nationwide and internationally to the folllowing states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV . In regards to foreign accounts, the product was distributed to Canada and British Columbia.
Product codes and lots
Model Number 915 Manufacturing Lot Number 45-03