FDA Medical Device Recalls (openFDA)
Engineered Medical Systems,Inc: 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. .
- Recall number
- Z-1058-2013
- Recalling firm
- Engineered Medical Systems,Inc
- 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. .
- Status
- Terminated
- Initiated
- 2011-09-12
- Posted
- 2013-04-10
- Terminated
- 2013-08-02
- Reason
- The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
- 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
- 1500pcs, 75cs {20pcs per cases)
- Distribution
- Distributed in the states of PA, IN, NY, CO, and CA.
- Lot, serial or model codes
- REF 8-205508-00 Lot Number: 820550800110419.
- 510(k) numbers
- K874746
- PMA numbers
- not on file
- Product code
- BSJ
- Firm FEI
- 1832562
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06