Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Reported: July 21, 2021 Initiated: April 30, 2021 #Z-2048-2021
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.
Details
- Recalling Firm
- RanD S.r.l.
- Units Affected
- 72
- Distribution
- The products were distributed to the following US states: FL, IL, TN, WI
- Location
- Medolla
Frequently Asked Questions
What product was recalled? ▼
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120. Recalled by RanD S.r.l.. Units affected: 72.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2048-2021.
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