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Parker Quality & Compliance

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Device recall

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG # PC37SGPHA

FDA recall source

Recall number
Z-0219-2027
Event id
100058
Status
Open, Classified
FDA classification
Class II
Recalling firm
Cardinal Health 200, LLC
Posted
Nov 2, 2026
Initiated
Sep 24, 2026
Product code
OKE
Device type
Port Introducer Kit
Reason
Kits contain infusion sets which were recalled for performance issues.
Root cause
Nonconforming Material/Component
Quantity
112 kits
Code info
GTIN 382602846379 (ea) 50382602846374 (cs), LOT # 761270
Distribution
US and Canada
Location
Waukegan, IL