Z-2234-2011

MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo...

Name: Z-2234-2011 MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo...
Creator: Oridion Medical 1987 Ltd.
Published: 2011-03-25
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2011-03-25 / Terminated / root cause: manufacturing process

FDA source

Oridion Medical 1987 Ltd. began a recall of MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter... on 2011-03-25. The reason FDA records is "fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2234-2011
Status: Terminated
Initiated: 2011-03-25
Posted: 2011-05-25
Terminated: 2012-03-19
Recalling firm: Oridion Medical 1987 Ltd.
Product: MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient
Root cause tag: manufacturing process
FDA root cause: 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 [email protected].
Quantity in commerce: 9,850 units in US (394 boxes with 25 units ea)
Distribution: Worldwide distribution.
Product codes and lots: Lot Numbers: M8286M10 M8300M10 M8406P10 M8544B11 M8555B11 M8575B11

Product code CCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)