Official recall record
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-07-23
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10198459445941
- Brand on record
- Medline Industries, LP
- Product category
- Medical Device
What the authority reported
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. 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, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-29.
Record last checked against the registry on 2026-09-29.
Other recalls from this brand
- 2026-08-11 · US FDA — Medical Devices
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; - 2026-08-11 · US FDA — Medical Devices
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catal - 2026-08-11 · US FDA — Medical Devices
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC0103
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