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

1

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

Date	Severity	Status	Recall #	Product	Code	Reason
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