Irrigation/Aspiration probe 16 holes, 5mmx45cm
Promepla · Model RF16H545 · UDI-DI 03700512901471
GBX
Prescription
10
510(k) clearances
5,795
Adverse events (26 deaths)
82
Recalls
239
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2025-11-07 | Rocket Medical Plc | IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use. |
| 2024-03-27 | Cardinal Health 200, LLC | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril |
| 2024-03-27 | Cardinal Health 200, LLC | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril |
| 2024-03-27 | Cardinal Health 200, LLC | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing steril |
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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.