Bottle Decanter recall: Sterility Concern
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).
Why was Bottle Decanter 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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).
- Recalling firm
- Microtek Medical Inc.
- Quantity
- 163 cases (8,150 units)
- Distribution
- Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)