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Recall Observatory FDA recall evidence

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

January 07, 2020

Class II

Product summary

Firm
Medline Industries Inc
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

    reason.no_named_rule · v1.0.0

    There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.