Z-0295-2018Class II

Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and...

Name: Z-0295-2018 Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and...
Creator: Medline Industries Inc
Published: 2017-07-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2017-07-18 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed... on 2017-07-18. FDA classified it as Class II and gives the reason as "Product did not undergo correct sterilization procedures and may potentially be non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0295-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-18
Posted: 2017-12-29
Terminated: 2020-04-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Product code: FQM Bandage, Elastic
Reason for recall: Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline sent a Recall Notification Letter dated July 18, 2017 to affected via USPS 1st Class Mail. The instructions included to check inventory and quarantine affected product, complete and return the response form, arrange return of affected product, and to notify customers if the product was further distributed. For questions contact 866-359-1704.
Quantity in commerce: 5,722 units total
Distribution: Worldwide Distribution - US Nationwide in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, WA and the countries of Canada, Saudi Arabia, and Netherlands.
Product codes and lots: Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0295-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-28

Product code FQM

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)