The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2049-2021·Announced 2021-07-21

Silicone thoracic/abdominal catheter recall due to potential sterilization defect

RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.

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: This is an FDA Class II recall involving a potential sterilization process failure. No illnesses or injuries have been reported. The source indicates some units may not be sterile, representing a theoretical risk rather than confirmed contamination, consistent with the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

RanD S.r.l. is recalling Ch24 round silicone catheters (diameter 8 mm, reference code R9900099) used for thoracic and abdominal cavity drainage. The sterilization contractor identified a possible quality issue in the sterilization process that may have resulted in some units not being sterile.

The affected lot is F180264, with 40 units distributed. The products were distributed to healthcare facilities in Florida, Illinois, Tennessee, and Wisconsin.

Healthcare providers and consumers who have received these products should discontinue use and contact RanD S.r.l. immediately. Healthcare facilities should review their inventory for the affected lot number and follow appropriate procedures for device handling and replacement.

The recalled product

Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Manufacturer
RanD S.r.l.
Category
Medical Device — Surgical Drain Catheters
Hazard
Affected units
40

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: F180264

Distribution

Distributed in 4 states:

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 →

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