Food, drugs, devices › Microtek Medical Inc.
Device recall: C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod
FDA enforcement event 94780 is a device recall by Microtek Medical Inc. of Saint Paul, MN, initiated 3 Jun 2024 and classified Class II, with 5 product records.
FDA defines Class II as 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Microtek Medical Inc. has 5 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Microtek Medical Inc., Saint Paul, MN.
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
"Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2639-2024 | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). | 10,366 cases (518,300 units) | Class II | Ongoing | 28 Aug 2024 |
| Z-2640-2024 | 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). | 135,999 cases (6,799,950 units) | Class II | Ongoing | 28 Aug 2024 |
| Z-2641-2024 | 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). | 163 cases (8,150 units) | Class II | Ongoing | 28 Aug 2024 |
| Z-2642-2024 | 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). | 30,435 cases (1,521,750 units) | Class II | Ongoing | 28 Aug 2024 |
| Z-2643-2024 | 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). | 11,781 cases (589,050 units) | Class II | Ongoing | 28 Aug 2024 |
Context
Other enforcement events for Microtek Medical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Apr 2025 | Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN | Device | Class II | 1 |
| 23 Jun 2023 | Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT | Device | Class II | 2 |
| 8 Apr 2022 | TMJ Arthroscopy Drape, 85''x 96'' | Device | Class II | 1 |
| 10 Mar 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STE | Device | Class II | 13 |
All 5 events for Microtek Medical Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.