Jerusalem/Needham MA (PRWEB) May 16, 2011
Recall Class: Class I
Date Recall Initiated: March 25, 2011
Part # - 006324
Part Description - FILTERLINE H SET INFANT/NEONATAL 25 UN
Lot Numbers -
Part # - 010807
Part Description - VITALINE H SET INFANT/NEONATAL 25UN
Lot Numbers -
Manufactured From: October 2010 to February 2011
Distributed From: October 2010 to March 2011
Use: CO2 monitoring during ventilation of infants and neonates.
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.
- Online: http://www.fda.gov/medwatch/report.htm1
- Regular Mail:
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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