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

Recall Z-2105-2013 — Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.

U.S. FDA — Device Enforcement · United States · 2013-07-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2105-2013
Date of alert
2013-07-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc. Cardiac Rhythm Disease Management
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
12096267
Reported risk: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
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.