Recall Z-2643-2024— Microtek Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Microtek Medical Inc., initiated 2024-06-03. It names one FDA 510(k) clearance: K811268. 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).. Reason: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film..
- Recalling firm
- Microtek Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-03
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.