CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Reported: September 17, 2014 Initiated: July 3, 2014 #Z-2570-2014
Product Description
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Reason for Recall
Unsealed pouches.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 1,400 units
- Distribution
- 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.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.. Recalled by CooperSurgical, Inc.. Units affected: 1,400 units.
Why was this product recalled? ▼
Unsealed pouches.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2014. Severity: Moderate. Recall number: Z-2570-2014.
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