Summary
The FDA issued a Class II for Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 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-2048-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Lot/Code Info: Lot Numbers: F180266 F180315 F190169
Quantity Affected: 72
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-2048-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29