Z-0017-2019Class II

Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103

Name: Z-0017-2019 Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103
Creator: Covidien Llc
Published: 2018-08-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-08-01 / Terminated / root cause: manufacturing process

FDA source

COVIDIEN LLC began a recall of Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging... on 2018-08-01. FDA classified it as Class II and gives the reason as "Potential for product sterility breach due to a compromised or pinched seal defect". 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-0017-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Posted: 2018-10-03
Terminated: 2020-06-03
Recalling firm: Medtronic, Inc.
Product: Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: Potential for product sterility breach due to a compromised or pinched seal defect
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices. 4. Notify any customers to whom you may have distributed product affected by this recall. 5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have: Hospital 800-964-5227 Federal Government 800-444-1166 Distributors800-635-6021 All other customers 888-444-5440 Customers with any questions regarding this letter may call (800) 292-9332.
Quantity in commerce: 2,730,821 units in total
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: 18D180662,18E070362,18E222362,18F072362

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0017-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0013-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02
Z-0014-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02
Z-0015-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02
Z-0016-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02
Z-0017-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02
Z-0018-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-02

Product code NAD

K990530Class IKerlix Md Antimicrobial Gauze DressingThe Kendall Company, L.P. / cleared 2000-01-31

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)