Agency classClass IIOur severity:High FDA (Devices)·Z-0068-2021·Announced 2020-10-14

Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

Medline Industries is recalling 16 non-sterile Left Heart Kits sold to facilities without sterilization capabilities. The kits were intended to be sterilized prior to use.

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 non-sterile medical devices sold to facilities without sterilization capabilities, creating a risk of infection or harm from use of non-sterile equipment. No injuries or illnesses have been reported, but the hazard is significant enough to warrant a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries Inc is recalling 16 units of Kit Model #65193091, MTO Left Heart Kit. These are non-sterile kits intended to be sterilized prior to use. The recall is limited to Lot 5619215, with an expiration date of 06/30/2023.

The recall was initiated because these non-sterile kits were sold to accounts that do not have the capabilities to sterilize them. The kits are used in Cath Lab and Interventional Radiology (IR) settings and consist of devices from the NAMIC Fluid Management product families.

The affected kits were distributed nationwide in the United States, including in California, Colorado, Connecticut, Ohio, Texas, and New York. Facilities that purchased these kits should stop using them and contact Medline Industries for instructions on return or replacement.

The recalled product

Product: Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original…
Manufacturer: Medline Industries Inc
Category: Medical Device — Surgical Kits
Hazard: infection
non-sterile
Affected units: 16

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 (2)

Lot 5619215
Exp 06/30/2023

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Medline Industries Inc 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 8 products in this recall →

Same manufacturer · Medline Industries Inc

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Same hazard · infection