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: 91

Is my product affected?

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+T

• UPC 07613327313956

Check against the official notice below — it lists the full affected range.

What happened

Stryker Neurovascular is recalling 71 units of Trevo Trak 21 Microcatheter and related Trevo NXT products (references 90338, 91412, 91413, and 91414) because the product label on the carton is missing the microcatheter product drawing or illustration. The affected products were distributed worldwide, including in the United States across California, Oregon, Pennsylvania, New York, Washington D.C., Illinois, Washington, New Hampshire, New Jersey, Oklahoma, Florida, Arizona, Alabama, Georgia, Texas, Wisconsin, Virginia, and in Delaware, Italy, and Austria.

The specific lot and reference numbers of the recalled products are identified in the recall notice. The source document does not specify a remedy for consumers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

Details from the source

Reason for recall: Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. 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. Quantity: 71 Lot/code info: REF/UDI/Lot: 90338/(01)07613327313956(17)231022(10)0000086176/0000086176; OUS: REF/Lot: 91412/46383767; 91413/46402565, 46383768, 46383779, 46383776; 91414/46383765, 46383772, 46383773, 46386864, 46383775, 46383774; 91415/46402572, 46383781, 46383771, 46383766; SFP914170/46383769; SFP914190/46383770

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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