Class 2 Device Recall PM1000 Flow Selector

• Date Initiated by Firm: March 05, 2010
• Date Posted: May 09, 2010
• Recall Status: Terminated 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
• FEI Number: 2523148
• 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: 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