Z-0358-2014 Class II Terminated
FDA device recall Z-0358-2014 was initiated by Wexford Labs Inc on September 10, 2013 and is designated Class II. Reason for recall: Expired active ingredient was used in the manufacture of the product. The recall status is terminated (terminated April 23, 2014). Affected quantity: 7,020/1-qt. bottles (1755 gallons).
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2013
- Initiation Date
- September 10, 2013
- Termination Date
- April 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,020/1-qt. bottles (1755 gallons)
Product Description
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
Reason for Recall
Expired active ingredient was used in the manufacture of the product.
Distribution Pattern
Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.
Code Information
Lot numbers 091721, exp. 10/13; 101521, exp. 11/13; 0109131, exp. 2/14; 0215131, exp. 3/14; 0320131, exp. 4/14; 0415132, exp. 5/14; 0516131, exp. 6/14; and 0624131, 7/14.