SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna
Summary
The FDA issued a Class II for SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica by Cordis Corporation. Reason: There is a potential for distal tip dislodgement or separation..
Details
Source
Device Recall
External ID
Z-0220-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Lot/Code Info: Product Code: SF10100SB; Lot No. 266586
Quantity Affected: 4 units
Reason for Recall
There is a potential for distal tip dislodgement or separation.
Distribution
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis Corporation have FDA actions?
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0220-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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