Device product
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
Z-0865-2020
Product summary
- Event
- Event 84665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500
- Official record key
device-enforcement:Z-0865-2020
Official wording
Reason: There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Code information: Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020
Distribution pattern: Kentucky. No governmental, Canadian, or Mexican consignees.
Derived failure modes
-
Unknown
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.