Device Recall Stroke Fast Pack(TM) 의 리콜

Recall

77671

Class 2

Z-2801-2017

2017-06-26

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157440

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.

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