Chest drainage unit instructions updated to specify adult patient population
Medline is recalling three surgical kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify the target patient population as adults.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the recall updates the instructions for use to clarify the intended patient population, and the source describes no defect in the devices.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Cardinal Health's Aqua-Seal Chest Drainage Unit: Open Heart (model DYNJ902487A), Cardiac Procedure (DYNJ908126) and Cardio Congenito (DYNJ910851). About 2,894 units were distributed in California and to Chile and Panama. The FDA has classified this recall as Class II.
The instructions for use on the specified Cardinal Health Chest Drainage Units and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. The source record does not describe a defect or malfunction in the devices themselves.
Each model carries its own UDI-DI and lot numbers, listed in the FDA enforcement record.
Facilities can identify affected kits by the model numbers, UDIs and lot codes, and may contact Medline Industries, LP for further information.
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 — Chest drainage
- Affected units
- 2,894
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
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