Home › Intersurgical Incorporated › TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR
TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR
Intersurgical Incorporated · Model 3241007 · UDI-DI 05030267153671
BSY
Prescription
10
510(k) clearances
3,474
Adverse events (42 deaths)
89
Recalls
248
Facilities
Description
TRACHSEALTM ADULT TRACHEOSTOMY CLOSED SUCTION SYSTEM WITH NACL AMPOULES, 24 HOUR, SIZE F16. PROCEDURE PACK
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.