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Regard™
ROI CPS, LLC · Model AN01084B · UDI-DI 10194717106982
OGD
Prescription
0
510(k) clearances
4
Adverse events
5
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2020-02-18 | Avid Medical, Inc. | The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is n |
| 2011-08-23 | Deroyal Industries, Inc. Lafollette | The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.