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U.S. Department of Health and Human Services

Class 1 Device Recall MICROSTREAM FILTERLINE ICU

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  Class 1 Device Recall MICROSTREAM FILTERLINE ICU see related information
Date Initiated by Firm April 07, 2011
Date Posted May 26, 2011
Recall Status1 Terminated 3 on March 14, 2013
Recall Number Z-2248-2011
Recall Event ID 58471
510(K)Number K980327  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Philips Microstream¿ Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS

These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.
Code Information Manufactured from October 2010 through February 2011. Product Number: 989803159581; Lot Code: M8409P10
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Lee Ann Rogus
978-659-4252
Manufacturer Reason
for Recall		 Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
FDA Determined
Cause 2		 Equipment maintenance
Action The firm, Philips, sent a Field Safety Notice titled "URGENT MEDICAL DEVICE RECALL" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the "Action to be taken by Customer/User" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.
Quantity in Commerce 75 units (3 boxes)
Distribution Worldwide distribution.
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 = CCK and Original Applicant = ORIDION MEDICAL LTD.
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