Z-1782-2014 Class II Terminated
FDA device recall Z-1782-2014 was initiated by CooperSurgical, Inc. on May 13, 2014 and is designated Class II. Reason for recall: Sterility of the device may be compromised due to unsealed pouch The recall status is terminated (terminated May 28, 2015). Affected quantity: 1180 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 18, 2014
- Initiation Date
- May 13, 2014
- Termination Date
- May 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1180 units
Product Description
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Reason for Recall
Sterility of the device may be compromised due to unsealed pouch
Distribution Pattern
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.
Code Information
Lot 141525
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1782-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026