Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medl

FDA device recall Z-1649-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

Action taken

Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.

Root cause

Employee error

Status

Terminated

Product code

FQM

Quantity affected

2,860 bandages

Distribution

Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.

Date initiated

2014-03-20

Date posted

2014-05-21

Date terminated

2017-11-29

Location

Mundelein, IL