Recall Z-0838-2020— Imactis

Name: FDA recall Z-0838-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-01

Class II · Ongoing

Class II FDA medical device recall by Imactis, initiated 2019-08-01. It names one FDA 510(k) clearance: K162314. 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..

Recalling firm: Imactis
Classification: Class II
Status: Ongoing
Initiated: 2019-08-01
Firm location: St Martin D Heres, France

510(k) clearances named in this recall

1 on FDA's record

K162314 — IMACTIS CT-Navigation systemImactis, Sas·cleared 2018-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.