Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
Cardinal Health is recalling 3,677 Presource Packs containing Stryker StrykeFlow PS and AHTO 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 hazard involves a risk of harm (slip and fall) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injuries.
Plain-English summary
Cardinal Health 200, LLC is recalling 3,677 Presource Packs that contain Stryker StrykeFlow PS and AHTO tube sets. The recall involves specific catalog numbers and lot numbers for kits used in laparoscopic cholecystectomy, cardio minimally invasive, robotic, and endocholecystectomy procedures. The affected products were distributed nationwide in California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio, and Texas.
The recall was initiated because the tube sets contain handpieces that may leak during use. This fluid leakage can pool on the floor, creating a potential slip and fall hazard for users. The impact of the defect ranges from user dissatisfaction to the risk of physical injury from slipping.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Cardinal Health 200, LLC for instructions on how to return the products or obtain a replacement. Users should verify the catalog numbers and lot numbers against the recall list to determine if their inventory is affected.
The recalled product
- Product
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 3,677
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) PGCGLCBAC
- UDI-DI: 10197106751749(each)
- 50197106751747(case)
- Lot Number: 24309FG2
- 2) PGCGLCBAC
- Lot Number: 24352FG2
- 3) PGCGLCBAC
- Lot Number: 24317FG2
- 4) PGCGLCBAC
- Lot Number: 25062FG2
- 5) PGCGLCBAD
- UDI-DI: 10198956230309(each)
- 50198956230307(case)
- Lot Number: 25121FG2
- 6) PGCGLCBAD
- Lot Number: 25045FG2
- 7) PGCGLCBAE
- UDI-DI: 10198956363366(each)
- 50198956363364(case)
- Lot Number: 25217FG2
Distribution
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