Z-0865-2020Class II

Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE...

Name: Z-0865-2020 Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE...
Creator: Medline Industries Inc
Published: 2020-01-07
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-01-07 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of 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... on 2020-01-07. FDA classified it as Class II and gives the reason as "There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0865-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-07
Posted: 2020-01-25
Terminated: 2020-09-16
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: LRP Tray, Surgical
Reason for recall: There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging
Action: Consignees notified by first class mail with formal recall letter dated January 07, 2020. The letter identified affected product, stated reason for recall, and requested product to be quarantined. A response form was requested to be returned via email.
Quantity in commerce: 500
Distribution: Kentucky. No governmental, Canadian, or Mexican consignees.
Product codes and lots: Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0865-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)