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U.S. Department of Health and Human Services

Class 2 Device Recall Battery Pack

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  Class 2 Device Recall Battery Pack see related information
Date Initiated by Firm June 04, 2004
Date Posted July 27, 2004
Recall Status1 Terminated 3 on January 06, 2005
Recall Number Z-1220-04
Recall Event ID 29333
Product Classification Monitor, Breathing Frequency - Product Code BZQ
Product Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
Code Information Model Number 915 Manufacturing Lot Number 45-03
Recalling Firm/
Respironics, Inc.
1010 Murry Ridge Ln
Murrysville PA 15668
For Additional Information Contact David Vanella, Director
Manufacturer Reason
for Recall
Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.