Medline Open Heart Surgical Kit Recall for Model Labeling Error
Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.
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 labeling/identification error on a high-risk surgical device used in open-heart procedures. Although no illnesses or injuries have been reported and this is a Class II recall, the potential for wrong-model selection in a critical surgical context constitutes a risk-of-harm scenario.
Plain-English summary
Medline Industries, LP is recalling certain MEDLINE OPEN HEART surgical kits (Reference DYNJ904261B) used in open-heart surgical procedures. The affected kits contain DLP Vessel Cannulae components.
During manufacturing, product intended for model 30001 was incorrectly labeled as model 30000. This labeling error could result in clinicians selecting and using the wrong model component during surgical procedures.
The recall affects approximately 30 units distributed throughout the United States. Healthcare facilities and surgical centers that received these kits should immediately verify the actual model of their equipment against the package label. Any kits with Lot Number 23LBR364 should be quarantined and not used pending verification. Facilities should contact Medline Industries for replacement kits or further guidance.
The recalled product
- Product
- MEDLINE OPEN HEART, REF DYNJ904261B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 30
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 (3)
- UDI/DI 40193489479530 (case)
- 10193489479539 (each)
- Lot Numbers: 23LBR364
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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