PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 5, 2020 Initiated: January 7, 2020 #Z-0865-2020

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.

Details

Recalling Firm
Medline Industries Inc
Units Affected
500
Distribution
Kentucky. No governmental, Canadian, or Mexican consignees.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Medline Industries Inc. Units affected: 500.
Why was this product recalled?
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2020. Severity: Moderate. Recall number: Z-0865-2020.