Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
FDA Recall Z-0277-2018 · Posted 2017-12-05
Advertisement
Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeNRY
Date Initiated2017-11-03
Date Terminated2019-11-04
Product Quantity1 unit
Reason for Recall
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs
were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Firm Action
The firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to [email protected].
If you have any questions, call 510-413-2593; email: [email protected] or 510-413-2900.
Root Cause
Labeling Change Control
Distribution Pattern
International Distribution to: Germany, Slovakia and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement