Z-2801-2017Class II

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM...

Name: Z-2801-2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM...
Creator: Stryker Neurovascular
Published: 2017-06-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-06-26 / Terminated / root cause: packaging

FDA source

Stryker Neurovascular began a recall of Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001 on 2017-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2801-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-26
Posted: 2017-07-29
Terminated: 2021-03-29
Recalling firm: Stryker Corp.
Product: Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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 [email protected]
Quantity in commerce: 139 packs
Distribution: nationwide
Product codes and lots: Lot Numbers: QPC40107530, QPC40107745, QPC40107814, QPC40110247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2801-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2799-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2800-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2801-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2802-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29

Product code NRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)