Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
Cardinal Health 200, LLC is recalling 344 Presource Packs containing Stryker tube sets because handpieces may leak fluid, creating a slip and fall hazard.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a risk of harm (slip and fall) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 344 Presource Packs that contain Stryker StrykeFlow PS and AHTO tube sets. The affected products include various GU DaVinci and Colorectal packs distributed nationwide in California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio, and Texas.
The recall is due to a defect where the handpieces in the tube sets may leak during use. This fluid leakage can pool on the floor, creating a potential slip and fall hazard for users. The impact of this defect ranges from user dissatisfaction to the risk of injury from slipping.
Healthcare facilities and users should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the affected products are found, they should be removed from use and returned to Cardinal Health 200, LLC according to the company's instructions.
The recalled product
- Product
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 344
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) PGVMDVBWU
- UDI-DI: 10888439626186(each)
- 50888439626184(case)
- Lot Number: 24317FG2
- 2) PGVMDVBWU
- Lot Number: 24353FG2
- 3) PGVMDVBWU
- 4) PGVMDVBWU
- Lot Number: 25069FG2
- 5) PGVMDVBWU
- Lot Number: 25045FG2
- 6) PGVMDVBWU
- 7) PGVMDVBWV
- UDI-DI: 10198956204034(each)
- 50198956204032(case)
- 8) PGVMDVBWV
- Lot Number: 25101FG2
- 9) PGVMDVBWV
- Lot Number: 25148FG2
- 10) PGVMDVBWV
Distribution
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