SEEKER(R) Crossing Support Catheter 의 리콜

Recall

79896

Class 2

Z-1802-2018

2018-04-16

2018-05-11

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163824

Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. the bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

The firm initiated the recall via an Urgent Medical Device Recall Notification letter on 04/16/2018. The letter identified the affected device, reason for the recall, and required actions. Customers are asked to check their inventory for and remove the affected product code and lot number combinations. The Recall and Effectiveness Check Form should be completed and returned even if affected product has been used. The firm requested the return of the recalled product; and will provide a replacement after all information has been verified and product returned. The completed form can be emailed to BPV.CustomerSupportCenter@crbard.com or faxed to 1-800-994-6772.