—#178976

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

FDA product code: LRP — Tray, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: Kentucky. No governmental, Canadian, or Mexican consignees.

Timeline

Recall initiated: 2020-01-07
Terminated: 2020-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178976. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.