Recall Z-2048-2021— RanD S.r.l.
Class II · Terminated
Class II FDA medical device recall by RanD S.r.l., initiated 2021-04-30, terminated 2024-02-05. It names one FDA 510(k) clearance: K161613. Product: Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120. 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..
- Recalling firm
- RanD S.r.l.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-30
- Terminated
- 2024-02-05
- Firm location
- Medolla, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.