Oridion Voluntarily Recalls FilterLine® H Set and VitaLine™ H Set Infant Neonatal CO2 Sampling Lines

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Recall Initiated March 25, 2011

Recall Class: Class I

Date Recall Initiated: March 25, 2011

Products:

Part # - 006324

Part Description - FILTERLINE H SET INFANT/NEONATAL 25 UN                                            

Lot Numbers -

M8286M10
M8300M10
M8406P10
M8544B11
M8555B11
M8575B11

Part # - 010807    

Part Description - VITALINE H SET INFANT/NEONATAL 25UN    

Lot Numbers -

M8535B11
M8573B11

Manufactured From: October 2010 to February 2011

Distributed From: October 2010 to March 2011

Use: CO2 monitoring during ventilation of infants and neonates.

Recalling Firm:
Oridion Capnography Inc.,
160 Gould Street

Needham, MA 02494

Reason for Recall:
The firm voluntarily recalled the Microstream units after learning dislodged plastic strands may be found within the airway adapter which may then become inhaled by the patient. The strands are typically 5 mm long and 100 microns in diameter, about the thickness of a human hair. FDA has been apprised of this action.

To date, the company has not received any reports of death or injury related to this issue. However, inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

Oridion is notifying its distributors and customers via a field safety notice and is arranging for replacement of all recalled products.

Customers with questions related to this recall should contact Oridion at 1-888-674-3466 ext 1234., Monday – Friday, 8:30 a.m. to 5:30 p.m., Eastern Standard Time.

Additional information on this recall can be found on the Oridion website at http://www.oridion.com
FDA District: New England

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

  • Fax: 1-800-FDA-0178

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Rachel Weissbrod
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