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.
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 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.
- 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
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.
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