Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0832-2013 — CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

U.S. FDA — Device Enforcement · United States · 2012-12-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0832-2013
Date of alert
2012-12-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Carefusion 303 Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
12055225
Reported risk: CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.