Z-0892-04

STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use...

Name: Z-0892-04 STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use...
Creator: Ventlab Corporation
Published: 2004-03-26
License: https://open.fda.gov/license/

Salter Labs / initiated 2004-03-26 / Terminated

FDA source

Ventlab Corporation began a recall of 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... on 2004-03-26. The reason FDA records is "In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0892-04
Status: Terminated
Initiated: 2004-03-26
Posted: 2004-07-20
Terminated: 2004-07-07
Recalling firm: Salter Labs
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
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
FDA root cause: Other
Action: Consignees were notified by letter on 3/26/2004.
Quantity in commerce: 520 units
Distribution: CA
Product codes and lots: Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06

Product code BTM

K982215Class IIManual Resuscitator with AceMedical Marketing Concepts / cleared 1998-09-18

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)