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Closed Suction Catheter
GCMEDICA ENTERPRISE LTD.(WUXI) · Model GC8061B12 · UDI-DI 06974500612145
BSY
Prescription
10
510(k) clearances
3,457
Adverse events (42 deaths)
89
Recalls
248
Facilities
Description
72H, FR12, Double swivel connector with 30.5cm tube, with one-way irrigation port
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 2025-03-19 | Avanos Medical, Inc. | Lack of sterility assurance for closed suction catheter systems |
| 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 |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
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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.