CooperSurgical Dilator/Sound Set recall
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Why was CooperSurgical Dilator/Sound Set recalled?
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 257589
- Product
- CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 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
- Recall date
- June 3, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)