Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling
Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.
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 recall of critical surgical instruments with a labeling error that could cause device misidentification during open heart procedures. No injuries have been reported, placing this in the High category per the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 123 kits of the Open Heart Pack (REF DYNJ66216C), which contain Medtronic DLP Vessel Cannulae. During manufacturing, certain units of model 30001 were incorrectly labeled as model 30000.
The recall affects kits distributed nationwide in the United States. The affected lot numbers are 23LBM368 and 23LBH354.
The labeling error could lead to use of incorrect device models during open heart surgical procedures, where proper instrumentation is critical to patient safety. Individuals and medical facilities who received kits from the affected lot numbers should review the product documentation and verify the actual model before use.
The recalled product
- Product
- MEDLINE OPEN HEART PACK, REF DYNJ66216C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 123
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 40193489853361 (case)
- 10193489853360 (each)
- Lot Numbers: 23LBM368
- 23LBH354
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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