The Recall Desk
HighFDA (Devices)·Z-2048-2021·Announced 2021-07-21

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.

What this means for you

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.
Category
Medical Device — Hyperthermic Perfusion Kit
Hazard
  • sterilization-failure
  • infection-risk

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

Distributed in 4 states:

  • FL
  • IL
  • TN
  • WI

Related recalls

Same category