Bottle Decanter, REF 2004S. Packaged on a form, fill and… recallZ-2641-2024 · Microtek Medical Inc. · initiated Jun 3, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Microtek Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

FDA root cause category: Device Design

What the company is doing

Consignees were notified via email and letter on 06/03/2024. The consignees were instructed to "Segregate Recalled Product/immediately examine the inventory for the lots listed above and remove all products from inventory regardless of its location and segregate this product in a secure location. The lot number can be found on the individual package or case label. If the consignee has affected product in their possession, please dispose of the product and packaging in accordance with hospital, administrative and /or local government policy. If the consignee is unable to dispose of the product, please contact the Customer Service team at the information provided below in this letter. The consignee is requested to please complete the enclosed Ecolab Customer Response Form and e-mail it to [email protected], whether they have affected product in their possession or not. If they need assistance with filling out the form, please contact the sales representative. If the consignee has further distributed this product, instead complete the enclosed Ecolab Distributor Response Form and e-mail it to [email protected] whether their customers have affected product in their possession or not. Please identify the consignee's customers and notify [email protected] so Ecolab may notify them of this Field Recall. It is important that the firm receive the completed Ecolab Customer Response Form or Ecolab Distributor Response Form by June 14, 2024. The consignee is instructed to please contact the Customer Service at 1-800-824-3027 from 8:30 a.m. to 5 p.m. (CST) to obtain a Returned Material Authorization (RMA) number if they are unable to dispose of the affected product, or email at [email protected] or [email protected]. The consignee is to package the decanter(s) that are being returned in an appropriate shipping box. Place a copy of the response form in the box, appropriately seal the box, and send it on or before June 14, 2024, to: ATTN: Belissa del Val

Recall details

Recall number: Z-2641-2024
Status: Open, Classified
Initiated by the company: Jun 3, 2024
Posted by the FDA: Aug 16, 2024
Recalling firm: Microtek Medical Inc.
Quantity: 163 cases (8,150 units)
Product code: KPE
FDA submissions: K811234
Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Product description

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

SKU/UDI-Device Identifier: 2004S/00748426002498; Lot Numbers: 200328,220321,220321,221220,221220,221102,220321,181127,220321,210506,200328,181127,200328,181127,181127,181127,200328,200328,180625,191113,220321,220321,220321,220321,210506,210506,210109,191113,200328,201115,200328,181127,181127,200328,181127,181127,181127,210506,191113,191113,180625,181127,221220,221102,220321,181127,220321,210506,210506,191113,200328,220321,220321,220321,200328,220321,220321,210506,210506,221220,221102,220321,180625,210109,191113,181127,210506,210506,181127,200328,200328,180625,180625,180625,181127,181127,180625,200328,191113,191113,181127,191113,200328,200328,220321,220321,220321,210506,210506,210506,210506,210109,200328,200328,200328,200328,200328,200328,200328,191113,181127,181127,200328,181127,181127,181127,181127,181127,200328,191113,191113,181127,180625,181127,221220,200328,181127,181127,200328,220321,220321,200328,210506,210506,210506,210506,210109,210109,201115,191113,200328,200328,200328,200328,200328,181127,181127,181127,180625,180625,181127,200328,191113,180625,181127,180625,181127,181127,181127,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,220321,220321,200328,200328,181127,181127,200328,181127,200328,191113,200328,191113,191113,220321,220321,220321,220321,220321,210506,210506,210506,210506,210506,210506,210506,210506,210506,210506,210109,210109,191113,200328,200328,200328,200328,200328,200328,181127,181127,200328,181127,200328,191113,181127,180625,200328,181127,191113,200328,181127,181127,181127,220321,210506,210109,200328,200328,191113,200328,181127,221220,221102,220321,200328,181127,180625,180625,191113,200328,200328,221102,220321,220321,191113,181127,181127,181127,210109,210109,200328,200328,200328,181127,221102,221220,221220,221220,221102,221102,221102,220321,220321,220321,181127,200328,200328,181127,181127,200328,181127,220321,210506,210506,210109,200328,200328,200328,200328,200328,200328,181127,181127,191113,181127,191113,200328,180625,180625,200328,181127,180625,181127,200328,220321,181127,221220,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,181127,210109,191113,191113,181127,220321,181127,191113,220321,200328,181127,221220,221220,220321,191113,191113,220321,191113,191113,200328,210109,210109,201115,201115,210109,200328,200328,191113,181127,181127,210506,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,220321,220321,220321,200328,221220,221102,180625,181127,181127,180625,191113,210506,210109,191113,200328,181127,200328,181127,180625,200328,221220,221220,221220,221102,221102,221102,220321,220321,220321

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

MICROTEK 1
Microtek Medical LLC · CONTAINER, I.V.
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 94780).

Z-2639-2024 · Open, Classified
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Z-2640-2024 · Open, Classified
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Z-2642-2024 · Open, Classified
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Z-2643-2024 · Open, Classified
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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