—#157444

Product

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150

FDA product code: NRY — Catheter, Thrombus Retriever
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Numbers: QXC10107745, QXC10107814, QXC10110247

Why it was recalled

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

Stryker notified their consignees by letter on 06/21/2017. The letter stated the following: This potentially impacts all 3-pack Stroke Fastpacks manufactured in the US. The product quality of the individual products in the Stroke Fastpack is not impacted. All units were manufactured to specification. We request that you read this notice carefully and complete the following actions: 1. Immediately check your internal inventory for impacted Catalog numbers. 2. Remove and discard the Stroke Fastpack carton sleeve. 3. Circulate this Field Safety Notice internally to all interested/affected parties. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete the form even if you no longer have any of the subject devices in your physical inventory. 8. Return the completed form to your nominated Stryker Representative or to NVFieldActions@stryker.com

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: nationwide

Timeline

Recall initiated: 2017-06-26
Terminated: 2021-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.