Z-0581-2022 Class III Terminated
FDA device recall Z-0581-2022 was initiated by Microbiologics Inc on October 8, 2020 and is designated Class III. Reason for recall: The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was prin… The recall status is terminated (terminated July 7, 2022). Affected quantity: 187 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- October 8, 2020
- Termination Date
- July 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187 units
Product Description
Reason for Recall
Distribution Pattern
US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam