Vial Decanter Medical Device Recalled for Compromised Sterile Packaging
Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial 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 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 is an FDA Class II recall with no reported illnesses or injuries. The documented defect—pin holes and tears in sterile packaging—represents a real risk of microbial contamination for a medical device, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microtek Medical Inc. has recalled its Vial Decanter (REF 2006S) due to defects in the sterile packaging film. During routine sterile barrier testing, the manufacturer identified pin holes and tears in the poly/Tyvek packaging material.
A compromised sterile barrier can allow microbial contamination, which poses a risk to patients and users of products stored or handled with affected units. Approximately 1.5 million units across 30,435 cases have been distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
Customers and healthcare facilities that received affected lots should stop using these products and contact Microtek Medical Inc. for replacement units or further guidance. No injuries or illnesses have been reported to date.
The recalled product
- Product
- Vial Decanter, REF 2006S. 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 (20)
- SKU/UDI-Device Identifier: 2006S/00748426002511
- Lot Numbers: 191216
- 191122
- 211019
- 210916
- 210604
- 210313
- 201017
- 181211
- 181212
- 191211
- 190627
- 190812
- 190617
- 200506
- 190531
- 190618
- 190808
- 210503
- 190609
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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