Recall Z-2248-2011 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Philips Healthcare Inc.
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
| Date | May 26, 2011 (initiated Apr 7, 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, 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 wh |
| Quantity | 75 units (3 boxes) |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980327 | MICROSTREAM FILTERLINE ICU Oridion Medical , Ltd., Apr 16, 1998 |