Imactis Navigation Kit Recalled for Potential Microbial Contamination
Imactis is recalling 122 Navigation Kits because the sensor cover may contain microbial contamination, posing a risk of pyrogenic response.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential pyrogenic response from endotoxin exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Imactis is recalling 122 units of the Imactis Navigation Kit (REF 10100) due to potential microbial contamination in the sensor cover component. The firm identified a source of microbial contamination in a raw product used to manufacture the tip of the cover. The affected lots are # 18120001 (Expiration: 2020-04-01) and # 19040001 (Expiration: 2021-01-22). The product is a single-use, sterile navigation kit compatible with linear instruments ranging from 0.5 mm to 3.0 mm in diameter.
The recall is being conducted because the microbial contamination 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. The agency has classified this as a Class II recall. The affected products were distributed in Wisconsin and Illinois.
Healthcare providers and consumers should stop using the affected Imactis Navigation Kits immediately. Users should check their inventory for the specific lot numbers and expiration dates listed above. For further information, contact the recalling firm, Imactis.
The recalled product
- 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…
- Manufacturer
- Imactis
- Affected units
- 122
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22
Distribution
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