Thoracic Catheter, Straight Fr 28
REDAX SPA · Model 20828 · UDI-DI 08034139292854
GBX
Prescription
10
510(k) clearances
5,795
Adverse events (26 deaths)
82
Recalls
239
Facilities
Description
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.