Z-2570-2014 Class II Terminated
FDA device recall Z-2570-2014 was initiated by CooperSurgical, Inc. on Jul 3, 2014 and is designated Class II. Reason for recall: Unsealed pouches. The recall status is terminated (terminated May 28, 2015). Affected quantity: 1,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 17, 2014
- Initiation Date
- Jul 3, 2014
- Termination Date
- May 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,400 units
Product Description
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Reason for Recall
Unsealed pouches.
Distribution Pattern
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.
Code Information
Lot 153914
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2570-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026