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Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl Gloves

Dynarex Corporation · Model 35001 · UDI-DI 00840117309685

LRQ Prescription
6
510(k) clearances
16
Adverse events (1 deaths)
4
Recalls
20
Facilities

Description

(1) Three-compartment tray (1) Pair of vinyl gloves (1) 3-Ply waterproof drape (4) Non-woven gauze, 4" × 4" (1) Tracheostomy dressing (2) Cotton-tipped applicators (1) Twill tape (2) Pipe cleaners (1) Tracheostomy brush

Recalls

DateFirmReason
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline 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
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline 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
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility
2019-12-11Centurion Medical Products CorporationIncomplete seals on the sterile package may compromise the sterility

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Data 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.