ORIDION MEDICAL 1987 LTD. — FDA Facility Profile
ORIDION MEDICAL 1987 LTD. is an FDA-registered facility (FEI 3001227743) located in JERUSALEM, IL. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2012: No Action Indicated (NAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Jun 15, 2011
- Warning letters
- 1 listed by FDA for this FEI, latest Oct 4, 2011
- Recalls as the recalling firm
- 2, latest Feb 17, 2025
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2012 | No Action Indicated (NAI) | No citations listed |
| Jun 15, 2011 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 17, 2025 | Not yet classified | Z-1376-2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF… and 9 more products Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may… |
| Jul 31, 2018 | Not yet classified | Z-0020-2019 | CAPNOSTREAM 20 (US) N, Part Number CS08651 and 36 more products The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is… |
Facility details
- Company
- Oridion Medical 1987 Ltd.
- Location
- JERUSALEM (IL)
- Source
- device