Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health S
Pending LLM rewrite. Source: FDA_DEVICE Z-1203-2026.
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 firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
The recalled product
- Product
- Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal
- Manufacturer
- Cardinal Health 200, LLC
- 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 (6)
- Dry Suction
- Wet Suction
- One Chamber
- Two Chamber System
- Three Chamber System
- 2500 mL 50192253002667 (CS) 10192253002669 (EA)
Distribution
Distributed nationwide across the United States.
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