The Recall Desk
HighFDA (Devices)·Z-2979-2018·Announced 2018-09-12

Medline Recalls Cardiac Insulation Pads Due to Sterilization Error

Medline Industries is recalling 77 kits of Cardiac Insulation Pads because a non-sterile component was not properly sterilized.

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: The recall involves a medical device where a component was not sterilized as required, creating a risk of harm (infection) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medline Industries, Inc. is recalling 77 kits of the Cardiac Insulation Pad, OPEN HEART CDS (Model CDS984745C). The recall involves specific lots identified in the agency record, including 17GD0936, 17FD1655, and 16AD4032. The affected products were distributed in California and New Mexico.

The recall was initiated because the Complete Delivery System (CDS) was assembled using a non-sterile cardiac insulation pad (component number 32369) that was placed in the non-sterile portion of the assembly. This component should have been placed in the sterile portion of the pack to undergo ethylene oxide sterilization. As a result, the item was released in a non-sterile state. The source text notes that the contents of the sterile kit were properly sterilized and the remaining non-sterile subassembly contents had the appropriate sterility status for their intended use.

Healthcare facilities and consumers who have these specific kits should stop using the affected cardiac insulation pads and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Cardiac Insulation Pad, OPEN HEART CDS
Manufacturer
Medline Industries, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
77

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 (17)

  • Model: CDS984745C
  • Lots: 17GD0936
  • 17FD1655
  • 17ED3419
  • 17ED1482
  • 17ED0636
  • 17DD0666
  • 17DD0296
  • 17AD1912
  • 16LD3005
  • 16LD0059
  • 16JD3201
  • 16ID3179
  • 16HD1298
  • 16GD0779
  • 16FD3925
  • 16CD0303 and 16AD4032

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Medline Industries, Inc.

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Same hazard · infection risk

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