Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
What this means for you
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: Medical device with compromised sterile barrier integrity (pin holes and tears in packaging) represents a risk-of-harm product where injury has not yet been reported, meeting Score 3 per the rubric criteria.
Plain-English summary
Microtek Medical Inc. is recalling the Transfer Device, REF 2008S. The device is packaged using a form, fill, and seal machine with poly/Tyvek material and supplied in cases of 50 units.
During sterile barrier testing, samples were found to have pin holes and tears in the packaging film. These defects compromise the integrity of the sterile barrier.
The recall affects 11,781 cases (589,050 units) distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. Multiple lot numbers are impacted.
Customers should immediately stop using affected Transfer Device units and contact Microtek Medical Inc. for instructions regarding return or replacement of the recalled products.
The recalled product
- Product
- Transfer Device, REF 2008S. 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.
- Hazard
- sterile-barrier-defect
- packaging-defect
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: 2008S/00748426002535
- Lot Numbers: 210924
- 190828
- 190312
- 190527
- 190507
- 190528
- 181022
- 181224
- 190717
- 181226
- 181225
- 190410
- 180828
- 211115
- 210924
- 210922
- 210923
- 210807
- 210805
Distribution
Distributed nationwide across the United States.
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