CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

PICC/CVC Secure Dressing Change kit recalled

Medical Action Industries is recalling PICC/CVC Secure Dressing Change kit, distributed nationwide in the US. The recall was initiated on 3 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit #73775, Lot 213403

Quantity recalled9 cases (180 kits)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1036-2016
FDA event ID: 73237
Recalling firm: Medical Action Industries, Arden, NC
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2016
FDA classified: 2 Mar 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

3 Feb 2016	Recall initiated by company
2 Mar 2016	Classified by FDA	+28 days
9 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Nationwide distribution to MO, NE and TX .

Nationwide Missouri Nebraska Texas

Questions about this recall

Is PICC/CVC Secure Dressing Change kit recalled?

Yes. Medical Action Industries recalled PICC/CVC Secure Dressing Change kit on 3 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1036-2016.

Why was it recalled?

Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

Which lots are affected?

Kit #73775, Lot 213403

Where was it sold?

Nationwide distribution to MO, NE and TX .

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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