Z-0749-2019 Class II Terminated
FDA device recall Z-0749-2019 was initiated by Kimberly-Clark Corporation on December 11, 2018 and is designated Class II. Reason for recall: Potential for tampon to come apart upon removal. The recall status is terminated (terminated June 2, 2021). Affected quantity: 68,852,076 units total.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2019
- Initiation Date
- December 11, 2018
- Termination Date
- June 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,852,076 units total
Product Description
U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
Reason for Recall
Potential for tampon to come apart upon removal.
Distribution Pattern
Nationwide distribution AR, AZ, CA, CT, FL, HI, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI. International distribution to Canada.
Code Information
Package UPC: 36000426649; Case UPC: 10036000426646; Lot Numbers: NN628101A, NN628101B, NN628201A, NN628201B, NN629401A, NN629401B, NN631201B, NN631301A, NN632113B, NN632213A, NN633813D, NN634113B, NN634213A, NN635113C, NN703113A, NN703113B, NN705613C, NN706313C, NN706313D, NN706413C, NN706413D, NN707713C, NN707713D, NN711313C, NN711313D, NN711413A, NN713013B, NN713113A, NN714313B, NN714413A, NN714413B, NN719313B, NN719413A, NN722013B, NN722113A, NN722113B, NN722213A, NN724713A, NN724713B, NN726713D, NN726813A, NN728213B, NN728313A, NN729613A, NN729613B, NN729713A, NN732513B, NN732613A, NN733913A, NN733913B, NN735213B, NN735313A, NN801413C, NN801413D, NN802813D, NN802913A, NN804213D, NN804313A, NN805813A, NN805813B, NN807513D, NN807613C, NN809913A, NN811213C, NN811213D, NN815413D, NN816813D, NN818113C, NN818113D, NN822413D, NN822513A, NN824613B, NN824713A, NN826713A.