Salter Labs
30 Spur Drive, El Paso, TX, US
Registered product codes
34 product codes
Recent MDR events
669 on file
- N/AJul 22, 2026Malfunction3004748541-2026-00138
- N/AJul 17, 2026Injury3004748541-2026-00120
- N/AJul 16, 2026Malfunction3004748541-2026-00137
- N/AJul 12, 2026Injury3004748541-2026-00119
- SALTER LABSJul 10, 2026Malfunction3004748541-2026-00127
- PARKERJul 10, 2026Malfunction3004748541-2026-00135
- N/AJul 10, 2026Injury3004748541-2026-00136
- SALTER O2 CANNULAJul 9, 2026Malfunction3004748541-2026-00130
- SALTER O2 CANNULAJul 9, 2026Malfunction3004748541-2026-00129
- SALTER O2 CANNULAJul 9, 2026Malfunction3004748541-2026-00131
Recalls
7 on file
- TerminatedFeb 10, 2016
Reports that the T-piece does not fit on the nebulizer.
View FDA record ↗ - TerminatedSep 17, 2015
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
View FDA record ↗ - TerminatedJul 23, 2014
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
View FDA record ↗ - TerminatedNov 19, 2013
It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
View FDA record ↗ - TerminatedJun 27, 2012
A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.
View FDA record ↗ - TerminatedJan 26, 2012
A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak.
View FDA record ↗ - TerminatedJan 11, 2012
Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
View FDA record ↗
Compliance history
Matched by FEI 3004748541.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.