Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous
Summary
The FDA issued a Class II for Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38 by Cook Incorporated. Reason: Product labels state the incorrect expiration dates that extends beyond their true expiration date.
Details
Source
Device Recall
External ID
Z-2223-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
Lot/Code Info: UDI: (01)00827002097674(17)270228(10)15923728 Lot Number: 15923728
Quantity Affected: 15 units
Reason for Recall
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Distribution
MA Foreign: Spain, and Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-15
Company
Bloomington, IN
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 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 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 (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2223-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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