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Philips Microstream Model 989803159581 VITALINE H SET… recallZ-2248-2011 · Philips Healthcare Inc. · initiated Apr 7, 2011

Terminated All recalls posted in May 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Healthcare Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-2248-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 7, 2011
Posted by the FDA
May 26, 2011
Recalling firm
Philips Healthcare Inc.
Quantity
75 units (3 boxes)
Product code
CCK
FDA submissions
K980327
Distribution
Worldwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

Manufactured from October 2010 through February 2011. Product Number: 989803159581; Lot Code: M8409P10

Other devices under the same FDA submission

6 devices cleared under K980327 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58471).

Sources and updates

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