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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 March 25, 2011
Date Posted May 25, 2011
Recall Status1 Terminated 3 on March 19, 2012
Recall Number Z-2236-2011
Recall Event ID 58373
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall.

The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
Code Information Lot Numbers: M8535B11 M8573B11
Recalling Firm/
Oridion Medical 1987 Ltd.
7 Hamarpe St., P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem Israel
For Additional Information Contact Dominic Corsale
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, Oridion, sent an "Microstream Filterline Field Correction Notice" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory. Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases. Oridion anticipates that new product will be available for shipment during the week of April 4th. Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.com.
Quantity in Commerce 300 units in US (12 boxes with 25 units ea)
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.