Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure
RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with sterilization failure. No illnesses or injuries are reported; however, non-sterile medical equipment presents a risk of harm.
Plain-English summary
Hang&Go (kit for hyperthermic perfusion, Reference Code R9900120) manufactured by RanD S.r.l. is being recalled. The recall involves 72 kits with lot numbers F180266, F180315, and F190169, distributed to Florida, Illinois, Tennessee, and Wisconsin.
RanD S.r.l.'s sterilization contractor identified a quality issue in the sterilization process. It was determined that some lots may not be sterile.
Persons with affected Hang&Go kits should contact RanD S.r.l. immediately for guidance on return or replacement.
The recalled product
- Product
- Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
- Manufacturer
- RanD S.r.l.
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: F180266 F180315 F190169
Distribution
Part of a larger recall action
This product is one of 2 recalled by RanD S.r.l. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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