Official recall record

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

US FDA — Medical Devices · 2026-07-23 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 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 2026-10-15.

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Other recalls from this brand

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