—#99462

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.

FDA product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K980327
Affected lot / code info: Manufactured from October 2010 through February 2011. Product Number: 989803159581; Lot Code: M8409P10

Why it was recalled

Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2011-04-07
Posted by FDA: 2011-05-26
Terminated: 2013-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.