CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Reported: June 3, 2020 Initiated: April 9, 2020 #Z-2112-2020
Product Description
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Reason for Recall
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 1740 units/174 boxes
- Distribution
- Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21. Recalled by CooperSurgical, Inc.. Units affected: 1740 units/174 boxes.
Why was this product recalled? ▼
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2112-2020.
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