Z-2641-2024 Class II Ongoing
FDA device recall Z-2641-2024 was initiated by Microtek Medical Inc. on June 3, 2024 and is designated Class II. Reason for recall: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. The recall status is ongoing. Affected quantity: 163 cases (8,150 units).
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2024
- Initiation Date
- June 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 cases (8,150 units)
Product Description
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).
Reason for Recall
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Distribution Pattern
Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
Code Information
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