Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099.
Summary
The FDA issued a Class II for Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total by RanD S.r.l.. Reason: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It.
Details
Source
Device Recall
External ID
Z-2049-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Lot/Code Info: Lot Numbers: F180264
Quantity Affected: 40
Reason for Recall
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
Distribution
The products were distributed to the following US states: FL, IL, TN, WI
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-30
Company
Medolla
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 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
RanD S.r.l. has 2 FDA actions in our database, including 2 recalls.
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 (RanD S.r.l.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RanD S.r.l. have FDA actions?
RanD S.r.l. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2049-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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