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AESCULAP
Aesculap AG · Model GF481R · UDI-DI 04046963368661
GCX
Prescription
10
510(k) clearances
1,734
Adverse events (21 deaths)
38
Recalls
194
Facilities
Description
RAABE Micro Suction Tube bending resistant, 7 1/4", (185 mm), working length: 5 1/2", (140 mm), diam. 2,70 mm, blunt, 4 rings, 8FR,green, non-sterile, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2025-12-26 | Cardinal Health 200, LLC | The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, |
| 2025-06-18 | Stryker Corporation | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2024-11-19 | Med Michigan Holding Llc | Incomplete or partial pouch seals, which may result in a breach in the sterility. |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2021-04-23 | Synaptive Medical Inc | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. |
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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.