Z-0525-2019Class II

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester...

Name: Z-0525-2019 Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester...
Creator: Aso, Llc
Published: 2018-10-16
License: https://open.fda.gov/license/

Aso LLC / initiated 2018-10-16 / Open, Classified / root cause: sterility

FDA source

ASO, LLC began a recall of Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count... on 2018-10-16. FDA classified it as Class II and gives the reason as "Potential that gauze pads may not be fully sterilized". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0525-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-10-16
Posted: 2018-11-30
Recalling firm: Aso LLC
Product: Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
Product code: NAB Gauze / Sponge,Nonresorbable For External Use
Reason for recall: Potential that gauze pads may not be fully sterilized
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form.
Quantity in commerce: 218 cases (72, 10-ct boxes per case)
Distribution: Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
Product codes and lots: ASO Item No. 780655, Batch/Lot # 2384-20180524

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0525-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code NAB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)