Z-2641-2024Class II

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed...

Name: Z-2641-2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed...
Creator: Microtek Medical Inc.
Published: 2024-06-03
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2024-06-03 / Open, Classified / root cause: design

FDA source

Microtek Medical Inc. began a recall of 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) on 2024-06-03. FDA classified it as Class II and gives the reason as "During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2641-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-03
Posted: 2024-08-16
Recalling firm: Microtek Medical LLC
Product: 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).
Product code: KPE Container, I.V.
Reason for recall: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 163 cases (8,150 units)
Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2641-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2639-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16
Z-2640-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16
Z-2641-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16
Z-2642-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16
Z-2643-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16

Product code KPE

K811234Class IIi.v. Bottle (Ridgid)Medi-Plast Intl., Inc. / cleared 1981-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)