Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This product presents a risk of harm due to compromised sterile barrier packaging on a medical device, which could allow contamination. The rubric classifies risk-of-harm products without reported injury as High (Score 3), and no illnesses or injuries have been reported in this case.
Plain-English summary
Microtek Medical Inc. is recalling Bottle Decanter, REF 2004S, due to defects in the sterile barrier packaging. During testing of the product line, samples were found to have pin holes and tears in the packaging film.
The packaging defect poses a risk that the sterile barrier could be compromised, potentially allowing contamination of the medical device. No illnesses or injuries have been reported at this time.
The recall affects 163 cases containing 8,150 units that were distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. Affected lot numbers are provided by the FDA.
Consumers and healthcare providers should stop use of affected units and contact Microtek Medical Inc. for instructions on return or replacement. Consult the FDA recall notice for specific lot numbers and product identifiers.
The recalled product
- 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).
- Manufacturer
- Microtek Medical Inc.
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 (12)
- SKU/UDI-Device Identifier: 2004S/00748426002498
- Lot Numbers: 200328
- 220321
- 221220
- 221102
- 181127
- 210506
- 200328
- 180625
- 191113
- 210109
- 201115
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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