Agency classClass IIOur severity:High FDA (Devices)·Z-1112-2023·Announced 2023-02-22

Medline CABG surgical convenience kits recalled due to sterility issue

Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.

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: FDA Class II medical device recall for a sterility assurance defect in surgical convenience kits. No illnesses or injuries have been reported, but the compromised outer packaging presents a potential risk of contamination or infection during surgical procedures.

Plain-English summary

Medline Industries is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432, GTIN 401934899531530) distributed nationwide with Reorder Number DYNDA2827.

The recall is due to a perforated bag design in the kits that does not maintain sterility of the outer kit wrapping. As a result, only the contents within the kit's inner wrapping can be assured to be sterile; the external wrapping may not meet sterility requirements.

This packaging defect creates a risk that surgical materials may be compromised by non-sterile outer packaging. Healthcare facilities that received these kits should verify their inventory against the affected lot number and contact Medline Industries for guidance on appropriate handling or return procedures. The U.S. Food and Drug Administration classified this as a Class II recall.

The recalled product

Product: Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Kits
Hazard: sterility-assurance
packaging-defect
Affected units: 80

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)

GTIN 401934899531530
Lot # 22HMH432

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 20 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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