FDA Device recall Z-0838-2020
Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref
- FDA Device
- Class II
- ongoing
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref by Imactis, citing the firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been ide….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0838-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-01 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Imactis |
| Distribution | IL, WI |
Product
Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,
Reason
The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
Identifiers
| code_info | Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2020%22
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