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. .
FDA Recall Z-1058-2013 · Posted 2013-04-10
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Recalling FirmEngineered Medical Systems,Inc
Recall StatusTerminated
Product CodeBSJ
Date Initiated2011-09-12
Date Terminated2013-08-02
Product Quantity1500pcs, 75cs {20pcs per cases)
Reason for Recall
The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Firm Action
Consignees were notified 9/12/2011 with a Medical Device Voluntary Recall letter identifying the product and the problem. Consignees were directed to quarantine, cease further distribution, and destroy the affected product, returning a proof of confirmation/disposal letter, to be submitted for credit. Correspondence should be sent to Tamara Lefevers, Quality Manager, at tlefevers@ engmedsys.com or fax 317-246-5501.
Root Cause
Process change control
Distribution Pattern
Distributed in the states of PA, IN, NY, CO, and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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