Recall Z-2049-2021 ยท LGZ Warmer, Thermal, Infusion Fluid
RanD S.r.l.
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
| Date | Apr 30, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | 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 |
| Quantity | 40 |
| Distribution | The products were distributed to the following US states: FL, IL, TN, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.