VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Summary
The FDA issued a Class II for VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; by Boston Scientific Corporation. Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility..
Details
Source
Device Recall
External ID
Z-3151-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Lot/Code Info: GTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027
Quantity Affected: 5 units
Reason for Recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Distribution
US, Colombia, Philippines, Russia
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
Company
Maple Grove, MN
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 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 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 (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3151-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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