Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-1562-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
The recalled product
- Product
- Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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 (20)
- 1) DYNJ902487A
- UDI-DI: 10193489496635(each)
- 40193489496636(case)
- Lot Number: 22KMG297
- 2) DYNJ902487A
- Lot Number: 22FMA481
- 3) DYNJ902487A
- Lot Number: 21IMG797
- 4) DYNJ902487A
- Lot Number: 21HMG569
- 5) DYNJ902487A
- Lot Number: 21HMB801
- 6) DYNJ908126
- UDI-DI: 10193489980110(each)
- 40193489980111(case)
- Lot Number: 26ABL637
- 7) DYNJ908126
- Lot Number: 25JBN467M
- 8) DYNJ908126
- Lot Number: 25JBN467
Distribution
Distributed nationwide across the United States.
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