FDAFDA · Food and drugs·Recall number Z-1782-2014
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Published June 18, 2014 · Recall initiated: May 13, 2014
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
Sterility of the device may be compromised due to unsealed pouch
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
- Lot
- Lot 141525
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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