Z-1407-2019 Class II Terminated
FDA device recall Z-1407-2019 was initiated by Remel Inc on April 17, 2019 and is designated Class II. Reason for recall: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. The recall status is terminated (terminated July 10, 2020). Affected quantity: 888 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 17, 2019
- Termination Date
- July 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 888 units
Product Description
Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Reason for Recall
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Distribution Pattern
Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.
Code Information
Material Number: R07180; Lot Number (Labeled Expiration Date): 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/2019), 330648 (01/21/2019), 333828 (01/24/2019), 337102 (01/31/2019), 343936 (02/14/2019), 347392 (02/28/2019), 353577 (03/06/2019), 366056 (03/28/2019), 367423 (04/02/2019), 370220 (04/09/2019), 377044 (04/22/2019), 380480 (04/29/2019), 390571 (05/16/2019), 391563 (05/20/2019), 407306 (06/20/2019), 418374 (07/18/2019).