FDAFDA · Food and drugs·Recall number Z-2570-2014
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Published September 17, 2014 · Recall initiated: July 3, 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
Unsealed pouches.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
- Lot
- Lot 153914
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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