FDA Device recall Z-0562-2019
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSi…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSi… by Civco Medical Instruments, citing the needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0562-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-02 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Civco Medical Instruments |
| Distribution | n/a |
Product
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
Reason
The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.
Identifiers
| code_info | Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Civco Medical Instruments
- eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments - eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
FDA Device · Class II · 2026-04-08 · Civco Medical Instruments
All Civco Medical Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0562-2019%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.