The Recall Desk
ModerateFDA (Devices)·Z-0865-2020·Announced 2020-02-05

Medline VP Tray Recall Due to Potential Sterile Barrier Compromise

Medline Industries is recalling 500 units of DYNDA1928 VP Trays because the sterile wrap may become loose in transit, compromising the sterile barrier.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential loss of sterility due to packaging integrity issues, which is a moderate risk but does not involve reported injuries or high-risk pathogens.

Plain-English summary

Medline Industries Inc. is recalling 500 units of the DYNDA1928 VP Tray with PVP. The product is sterile and was packaged in Mexico, with components including gloves made in Malaysia, an applicator made in China, and a winged sponge made in Mexico. The specific lot number is 2019032190, with an expiration date of 07/31/2020.

The recall was initiated because there is a potential for the sterile wrap to become loose while in transit. This issue could compromise the sterile barrier of the product. The affected units were distributed to Kentucky, with no governmental, Canadian, or Mexican consignees.

Consumers and healthcare facilities should stop using the affected product and contact Medline Industries for further instructions or a return.

The recalled product

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:M
Affected units
500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

Distribution

Distributed in 1 state: