Z-1036-2016Class II

PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries...

Name: Z-1036-2016 PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries...
Creator: Medical Action Industries Inc
Published: 2016-02-03
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2016-02-03 / Terminated / root cause: labeling and UDI

FDA source

Medical Action Industries Inc began a recall of PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to... on 2016-02-03. FDA classified it as Class II and gives the reason as "Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1036-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-03
Posted: 2016-03-02
Terminated: 2016-06-28
Recalling firm: Medical Action Industries, Inc. 306
Product: PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings
Product code: FRO Dressing, Wound, Drug
Reason for recall: Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting [email protected] . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.
Quantity in commerce: 9 cases (180 kits)
Distribution: Nationwide distribution to MO, NE and TX .
Product codes and lots: Kit #73775, Lot 213403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1036-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-02

Product code FRO

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)