Concentric Medical Recalls One Distal Access Catheter for Distribution Error
Concentric Medical Inc is recalling one Distal Access Catheter that was intended for distribution in Korea but was found at a US location in Kentucky.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a distribution error involving a single unit intended for another country, with no reported injuries, illnesses, or functional defects cited in the source text.
Plain-English summary
Concentric Medical Inc is recalling one unit of the Distal Access Catheter (Finished Good Number 90960-001 / REF 90960). The device is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary, and neuro vasculature systems.
The recall was initiated because the specific unit, identified by Lot no. 37603 with an expiration date of September 2016, was intended for distribution in Korea but was found at a US location. The distribution pattern indicates US distribution to one location in Kentucky.
This recall involves a single unit. No specific instructions for consumers are provided in the source text, but the device should not be used until further notice from the manufacturer or regulatory authorities.
The recalled product
- Product
- Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a se
- Manufacturer
- Concentric Medical Inc
- Category
- Medical Device — Cardiology
- Hazard
- Affected units
- 1
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 no. 37603 Expiration date: September 2016
Distribution
Distributed in 1 state:
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