FDA Device recall Z-0234-2019
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su…
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Su… by Ecolab, citing the pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0234-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-14 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ecolab |
| Distribution | US |
Product
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
Reason
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
Identifiers
| code_info | Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177,…Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177, D173477, D180087, D173187, D173137, D172987, D173217, D173067, D173497, D173447, D173427, D173287, D180167, D180027, D173577, D173077, D180097, D180157, D173627, D173607, D173467, D173567, D180197, D173257, D173637, D173457, D180267, D180257, D172997, D173547, D180317, D180237, D173227, D173537, D173507, D180107, D173617, D173267, D180247, D173197, D180057, D180187, D180347, D180337, D180377, D180037, D180307, D180437, D173017,and D180507. |
|---|
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-0234-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.