Recall Z-1058-2013— Engineered Medical Systems,Inc

Name: FDA recall Z-1058-2013
Creator: U.S. Food and Drug Administration
Published: 2011-09-12

Class I · Terminated

Class I FDA medical device recall by Engineered Medical Systems,Inc, initiated 2011-09-12, terminated 2013-08-02. It names one FDA 510(k) clearance: K874746. Product: Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .. Reason: The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates..

Recalling firm: Engineered Medical Systems,Inc
Classification: Class I
Status: Terminated
Initiated: 2011-09-12
Terminated: 2013-08-02
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K874746 — SEALFLEX MASKEngineered Medical Systems·cleared 1987-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

Reason for recall

The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.