SealFlex Infant Medical Mask Recall Issued Due to Labeling Error

Federal health regulators have determined that SealFlex ribbed infant masks shipped to hospitals in five states could pose a serious risk for young children, because they were mislabeled as infant sized when they are actually neonatal sized.  

The FDA determined this week that a SealFlex Single Port Ribbed Mask recall qualifies as a Class 1 medical device recall, which suggests that the agency believes the devices could lead to serious injury or death.

The masks are typically used in general respiratory situations and to administer anesthesia and other gases, such as oxygen, to patients during medical procedures and during emergency situations. Masks used in these situations must fit snugly and correctly in order for the correct amount of gas to be administered to the patients.

The recall was first initiated in September 2011, impacting any masks distributed in Pennsylvania, Indiana, New York, Colorado and California from April 21, 2011, through August 24, 2011.

The recall affects the SealFlex Single Port Ribbed Mask (Infant) with a Part/Reference number of 8-205508-00 and a lot number of 820550800110419. The masks are sold by Engineered Medical Systems, Inc. Based in Indianapolis, Ind. and distributed by Respironics Novametrix, LLC in Wallingford, CT.

The masks were initially packaged and marked as infant sized masks, but were later determined to be neonatal sized. Using an ill-fitting mask may cause serious medical side effects. A smaller than necessary mask can result in incorrect dosages of gas, either too much or too little, being fully administered. In some cases it may even result in death.

Engineered Medical Systems issued a voluntary recall letter to Respironics to identify the product and the problem. Respironics then issued a letter to customers informing them of the recall.

The recall letter asks customers to identify the recalled product, remove it from inventory and discontinue use. It also instructs customers to segregate the product from other masks being used and to destroy the affected masks. They are then asked to return the proof of confirmation disposal letter to Respironics Novametrix Quality Supervisor to receive credit for the product.

A class 1 recall is the most serious type of medical device recall issued. It is issued when there may be significant potential for a product to cause severe adverse events or result in death. No reports of serious injury or death related to SealFlex Single Port Ribbed Infant Masks have been reported at this time.

Customers can contact Respironics Novametrix Customer Service at 877-387-3311. They can also report any adverse events resulting from the SealFlex Mask to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.