Recall Z-1386-2022 ยท DQO Catheter, Intravascular, Diagnostic
Stryker Neurovascular
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, REF: SFP914190. Used in the placement of devices and/or fluids, such as c
| Date | Jun 3, 2022 |
| Status | Open, Classified |
| Reason | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. |
| Root cause | Labeling mix-ups |
| Action | On 06/03/22 Field Action notifications were mailed to customers who were informed of the following: 1) The affected items may continue to be used. Refer to the inner pouch label for the product drawing/illustration. 2) Circulate and maintain awareness of this Customer Notification internally to all interested/affected parties. 3) Inform the recalling firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that the recalling firm can inform the recipients appropriately. 7. Please inform the recalling firm of any adverse events concern |
| Quantity | 71 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192122 | Trevo Trak 21 Microcatheter Stryker, Nov 22, 2019 |