C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with sterile barrier packaging defects discovered through proactive quality testing with no reported illnesses, injuries, or confirmed contamination. Precautionary recall based on theoretical contamination risk.
Plain-English summary
Microtek Medical Inc. is recalling C-Flow Bag Decanter, REF 2000S (10,366 cases; 518,300 units) due to defects in sterile barrier packaging. During sterile barrier testing, samples were identified to have pin holes and tears in the packaging film, which consists of poly/Tyvek material applied via form, fill, and seal machinery.
The packaging defects could compromise the sterile barrier integrity, potentially allowing bacterial or microbial contamination of the product. This poses an infection risk if contaminated units are used clinically.
The recalled product was distributed nationwide and internationally, including to Canada, Mexico, New Zealand, Belize, and Hong Kong. Healthcare facilities and consumers with affected units should contact Microtek Medical Inc. for guidance on product replacement or proper disposition.
The recalled product
- Product
- 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).
- Manufacturer
- Microtek Medical Inc.
- Category
- Medical Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SKU/UDI-Device Identifier: 2000S/00748426002085
- Lot Numbers: 190220
- 200424
- 191214
- 191025
- 191118
- 211024
- 210602
- 211016
- 210912
- 210727
- 210828
- 210608
- 210411
- 210323
- 210118
- 210113
- 201123
- 201009
- 200423
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Microtek Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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