Class 2 Device Recall Bottle Decanter

• Date Initiated by Firm: June 03, 2024
• Date Posted: August 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2641-2024
• Recall Event ID: 94780
• 510(K)Number: K811234
• Product Classification: Container, i.V. - Product Code KPE
• 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).
• Code Information: 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
• FEI Number: 3014342658
• Recalling Firm/ Manufacturer: Microtek Medical Inc.; 1 Ecolab Pl; Saint Paul MN 55102-2739
• Manufacturer 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.
• FDA Determined 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 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
• Quantity in Commerce: 163 cases (8,150 units)
• Distribution: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPE