FDA Medical Device Recalls (openFDA)
Ventlab Corporation: STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
- Recall number
- Z-0892-04
- Recalling firm
- Ventlab Corporation
- Product
- STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
- Status
- Terminated
- Initiated
- 2004-03-26
- Posted
- 2004-07-20
- Terminated
- 2004-07-07
- Reason
- In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
- Root cause
- Other
- Action
- Consignees were notified by letter on 3/26/2004.
- Quantity
- 520 units
- Distribution
- CA
- Lot, serial or model codes
- Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
- 510(k) numbers
- ["K982215"]
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 1314417
- Firm city
- Mocksville
- Firm state
- NC
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28