Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Recall
- Recall Number
- Z-2049-2021
- Event Number
- 87926
- Firm
- RanD S.r.l. Strada Statale 62 Medolla Italy
- FEI Number
- 3003793891
- Product Code
- LGZ
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- April 30, 2021
- Terminated
- February 5, 2024
Description
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
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.
An Urgent Medical Device Recall notification letter dated 4/30/21 was sent to customers. Reason for the Voluntary Recall: Our sterilization contractor informed us about a quality issue possibly affecting the sterilization process of a certain number of RAND products, thus leading us to open an immediate investigation. We have determined that the lots mentioned in the table below may be non-sterile. Risk to Health: The exposure to non-sterile products may result in an increased risk of patient infection. However we have not received any adverse event report regarding patient infection events associated with this field safety notice, so far. No specific follow up activities are required if the products have already been used. Actions to be taken by the Customer/User: Please proceed as follows: 1. Please check if you still have in your stock products belonging to the lot numbers below. Please refer to the reference code (REF) and the lot number (LOT) on the product label. 2. If you identify affected product, cease use immediately and put these products in quarantine. Please be sure that they are properly and clearly identified as on-hold to prevent their unintentional use. 3. Please fill in the form on the last page and return it to [email protected] as soon as possible, but no later than May 30, 2021. The form must be completed and returned even if you do not have affected product on hand. 4. If you identified non-conforming products in your inventory, you will receive further instructions on product disposition (return them to RAND or destroy them). Type of Action by the Company: No alternative products can be used, because only RanD sterile medical devices can be used in combination with the Performer HT equipment. RanD S.p.A. has already validated a different sterilization provider. New sterile products will be available in 1 - 2 month time. Contact details: If you have any questions or concerns regarding this notification, d
The products were distributed to the following US states: FL, IL, TN, WI
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