FDA Device recall Z-2333-2018
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/sh…
- FDA Device
- Class III
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class III recall of ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/sh… by Ecolab, citing the incorrect IFU was shipped with the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2333-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-22 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ecolab |
| Distribution | CA, IL, LA, SC, TX, WI |
Product
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
Reason
The incorrect IFU was shipped with the product.
Identifiers
| code_info | Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2333-2018%22
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