FDAFDA · Food and drugs·Recall number Z-1195-2013
Presource PBDS, General Laparoscopy, Kit, Circulator
Published May 15, 2013 · Recall initiated: March 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health, Medical Products & Services
- Distributor
- Distributed in the states of AR, MS, SC, and TN.
- Lot
- Catalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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