Z-0838-2020 Class II Ongoing
FDA device recall Z-0838-2020 was initiated by Imactis on August 1, 2019 and is designated Class II. 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 pro… The recall status is ongoing. Affected quantity: 122 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- August 1, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122 kits
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.
Distribution Pattern
US: WI & IL
Code Information
Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22