RanD S.r.l.: Medical Device Recall in 2021 - (Recall #: Z-2049-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 30, 2021

Date Posted: July 21, 2021

Recall Number: Z-2049-2021

Event ID: 87926

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.

Status: Terminated

Product Quantity: 40

Code Information:

Lot Numbers: F180264

Distribution Pattern:

The products were distributed to the following US states: FL, IL, TN, WI

Voluntary or Mandated:

Voluntary: Firm initiated