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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Trays
- 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:
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