Recall Z-2799-2017— Stryker Neurovascular
Class II · Terminated
Class II FDA medical device recall by Stryker Neurovascular, initiated 2017-06-26, terminated 2021-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001. Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack..
- Recalling firm
- Stryker Neurovascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-26
- Terminated
- 2021-03-29
- Firm location
- Fremont, CA, United States
Product description
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
Reason for recall
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.