FDAFDA · Food and drugs·Recall number Z-1722-2019
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Published June 12, 2019 · Recall initiated: April 9, 2019
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
Affected products may have been manufactured with the catheter distal end hole too small
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
- Lot
- Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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