Z-1058-2013Class I

Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia...

Name: Z-1058-2013 Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia...
Creator: Engineered Medical Systems,Inc
Published: 2011-09-12
License: https://open.fda.gov/license/

Engineered Medical Systems, LLC / initiated 2011-09-12 / Terminated / root cause: labeling and UDI

FDA source

Engineered Medical Systems,Inc began a recall of Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate... on 2011-09-12. FDA classified it as Class I and gives the reason as "The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1058-2013
Classification: Class I
Status: Terminated
Initiated: 2011-09-12
Posted: 2013-04-10
Terminated: 2013-08-02
Recalling firm: Engineered Medical Systems, LLC
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. .
Product code: BSJ Mask, Gas, Anesthetic
Reason for recall: The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Root cause tag: labeling and UDI
FDA root cause: Process change control
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.
Quantity in commerce: 1500pcs, 75cs {20pcs per cases)
Distribution: Distributed in the states of PA, IN, NY, CO, and CA.
Product codes and lots: REF 8-205508-00 Lot Number: 820550800110419.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10

Product code BSJ

K874746Class ISealflex MaskEngineered Medical Systems / cleared 1987-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)