Medical Devices

Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant)

Recall Class: Class I

Date Recall Initiated: September 12, 2011

Product: SealFlex Single Port Ribbed Mask (Infant)

  • Part/Reference Number 8-205508-00, Lot Number:  820550800110419

These masks were distributed in Pennsylvania, Indiana, New York, Colorado, and California from April 21, 2011 through August 24, 2011.

Use:  For general use in respiratory and anesthesia purposes as a delivery mechanism for various gases.

Recalling Firm:
Engineered Medical Systems, Inc.
2055 Executive Drive
Indianapolis, Indiana  46241-4311

Distributor:
Respironics Novametrix, LLC
5 Technology Drive
Wallingford, CT 06492

Reason for Recall: The mask inside the package has been identified as “Neonatal” in size and not “Infant” as the labeling indicates.  The use of an improperly-sized mask may cause serious adverse health consequences, including death.

Public Contact:   For questions about this recall, please contact Respironics Novametrix Customer Service at 1-877-387-3311.

FDA District: Detroit District Office

FDA Comments:  
On September 12, 2011, Engineered Medical Systems sent a Medical Device Voluntary Recall letter to its distributor, Respironics Novametrix, identifying the product and the problem. Respironics Novametrix followed up with its own letter to their customers informing them of the recalled product and problem. Respironics Novametrix requested their customers to:

  • identify all affected products;
  • remove the affected products from their inventory;
  • segregate them in a secure location;
  • cease further distribution;
  • destroy the affected products;
  • return the proof of confirmation/disposal letter (to be submitted for credit) to Respironics Novametrix, Attn: Quality Supervisor by fax at 203-284-0753 (even if they did not purchase the affected product).

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.

Page Last Updated: 04/24/2013
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