Chrysalis Intelligence · Sponsors · Microtek Medical, LLC

Microtek Medical, LLC

Northfiled, IL, US · 1 510(k) clearances · 9 recalls

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Total clearances
1
2025-09-16 → 2025-09-16
Last 12 months
0
Product codes
1
Most recent
2025-09-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LHI Set, I.V. Fluid Transfer Class II General Hospital 1 2025-09-16
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
8
Most recent
2025-04-13
DateSeverityStatusRecall # ProductCodeReason
2025-04-13 Class II Ongoing Z-1963-2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 … — Due to non-sterile products being labeled as sterile
2024-06-03 Class II Ongoing Z-2643-2024 Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products… — During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
2024-06-03 Class II Ongoing Z-2642-2024 Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products t… — During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
2024-06-03 Class II Ongoing Z-2641-2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products… — During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
2024-06-03 Class II Ongoing Z-2640-2024 Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products… — During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
2024-06-03 Class II Ongoing Z-2639-2024 C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod… — During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
2023-06-23 Class II Ongoing Z-2251-2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &… — Certain lots of the products have a Naphthalene odor.
2023-06-23 Class II Ongoing Z-2250-2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 6362… — Certain lots of the products have a Naphthalene odor.
2022-04-08 Class II Terminated Z-1071-2022 TMJ Arthroscopy Drape, 85''x 96'' — Latex content in product was labeled incorrectly as latex free.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-09-16 K251676 Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) LHI Class II General Hospital
Data source: openFDA · Generated 2026-09-17 10:01 · Last ingest 2026-09-17T14:00:49.726243 · Pipeline: Chrysalis Intelligence