Recall Z-2233-2011 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (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 partia
| Date | May 25, 2011 (initiated Mar 25, 2011) |
| Status | Terminated |
| Reason | fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient |
| 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 produc |
| Quantity | 350 units in US (14 boxes with 25 units ea) |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.