Z-0865-2020 Class II Terminated
FDA device recall Z-0865-2020 was initiated by Medline Industries Inc on January 7, 2020 and is designated Class II. Reason for recall: There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier. The recall status is terminated (terminated September 16, 2020). Affected quantity: 500.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500
Product Description
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico
Reason for Recall
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Distribution Pattern
Kentucky. No governmental, Canadian, or Mexican consignees.
Code Information
Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020