FDA recall Z-0865-2020

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

Reason for recall

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

Distribution

Kentucky. No governmental, Canadian, or Mexican consignees.

Key facts

Status

Terminated

Initiation date

2020-01-07

Report date

2020-02-05

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2020