Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Reported: August 28, 2024 Initiated: June 3, 2024 #Z-2640-2024
Product Description
Bag Decanter II, REF 2002S. 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.
Details
- Recalling Firm
- Microtek Medical Inc.
- Units Affected
- 135,999 cases (6,799,950 units)
- Distribution
- Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).. Recalled by Microtek Medical Inc.. Units affected: 135,999 cases (6,799,950 units).
Why was this product recalled? ▼
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2640-2024.
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