Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling
Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.
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: This is a Class II medical device recall involving a labeling error on a cardiac surgery product. Although no injuries have been reported, the mislabeling of a surgical device represents a risk of harm due to potential incorrect use. Under the rubric, risk-of-harm products with no reported injury warrant a High severity score.
Plain-English summary
Medline Industries, LP is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae (Reference CDS983376R). During manufacturing, products for model 30001 were mislabeled as model 30000.
The affected lot numbers are 24BMF012 and 24CMG491. These kits were distributed nationwide in the United States. The model labeling discrepancy could result in incorrect product identification during use.
Healthcare facilities and distributors that received these lots should check their inventory against the affected lot numbers and contact Medline Industries, LP with the lot information for return or replacement instructions.
The recalled product
- Product
- MEDLINE HEART CABG CDS, REF CDS983376R
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Cardiac Surgery
- Hazard
- Affected units
- 15
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 (4)
- UDI/DI 40195327548545 (case)
- 10195327548544 (each)
- Lot Numbers: 24BMF012
- 24CMG491
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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.
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