The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2492-2020·Announced 2020-07-15

Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues

Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.

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: The recall involves a medical device with a sterility assurance issue, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Prodimed Plastimed Division is recalling 2,580 units of Combicath Paediatric catheters for blind protected distal bronchial sampling (Product Code: 58 223 19). The recall was initiated because of a lack of assurance of sterility for the affected devices.

The affected products were distributed nationwide. The recall includes all lots within their expiry dates. No specific lot numbers or dates are provided in the source text.

Healthcare providers and consumers should stop using these catheters and contact Prodimed Plastimed Division for further instructions or a return.

The recalled product

Product
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Manufacturer
Prodimed Plastimed Division
Category
Medical Device — Catheters
Hazard
Affected units
2,580

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)

  • All lots within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Prodimed Plastimed Division 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 6 products in this recall →

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