RecallRadar

FDA Device recall Z-0865-2020

Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000…

On 2020-02-05 the FDA classified a Class II recall of Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000… by Medline Industries, citing there is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0865-2020
ClassificationClass II
Statusterminated
Initiated2020-01-07
Published2020-02-05
Last updated2026-09-13 11:55 UTC
CompanyMedline Industries
DistributionKY

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

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

Identifiers

code_infoCode DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2020%22

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