Bottle Decanter (Microtek Medical) – Packaging Integrity Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Microtek Medical Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Microtek Medical Inc. is recalling Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material the due to During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Recommended Action
Per FDA guidance
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 recall@ecolab.com, 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 recall@ecolab.com whether their customers have affected product in their possession or not. Please identify the consignee's customers and notify recall@ecolab.com 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 csdomesticorders@ecolab.com or cs-distributorrequests@ecolab.com. 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026