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U.S. Department of Health and Human Services

Class 2 Device Recall PM1000 Flow Selector

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  Class 2 Device Recall PM1000 Flow Selector see related information
Date Initiated by Firm March 05, 2010
Date Posted May 09, 2010
Recall Status1 Terminated 3 on December 13, 2010
Recall Number Z-1561-2010
Recall Event ID 55117
510(K)Number K843223  
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.
Code Information Lot numbers 1209 and 0110
Recalling Firm/
Manufacturer		 Precision Medical, Inc.
300 Held Dr
Northampton PA 18067-1150
For Additional Information Contact Customer Service
610-262-6090
Manufacturer Reason
for Recall		 The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"
FDA Determined
Cause 2		 Labeling mix-ups
Action The recalling firm issued Customer Alert Product Recall letters on 3/5/10 to inform users of the problem and how to identify affected product.
Quantity in Commerce 19,518
Distribution The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
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.
510(K) Database 510(K)s with Product Code = BTM and Original Applicant = PRECISION MEDICAL, INC.
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