Medline Open Heart A Pack Kits Recalled for Sterility Concerns
Medline is recalling 135 Open Heart A Pack kits in California due to a potential sterile barrier breach in the RCSP cannulae, posing a risk of infection.
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 with a potential sterile barrier breach, creating a risk of infection and serious complications (hemolysis, thromboembolism) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 135 units of the Medline Convenience Kit: OPEN HEART A PACK (Product Number DYNJ43008N). The recall is limited to distribution in the state of California. The affected units include specific lot numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, and 26CLA372.
The recall is being issued because the kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. As a result, the sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device.
Potential complications from using a non-sterile device include hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction. Healthcare providers and consumers should check their inventory for the specific product number and lot numbers listed above and stop using the affected kits immediately.
The recalled product
- Product
- Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 135
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 (7)
- UDI-DI: 10198459445941 (each)
- 40198459445942 (case)
- Lot Numbers: 25HLA462
- 25HLA916
- 25JLA847
- 25LLA298
- 26CLA372
Distribution
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