The Recall Desk
ModerateFDA (Devices)·Z-1036-2016·Announced 2016-03-09

Medical Action Industries Recalls PICC/CVC Dressing Kits Due to Misbranding

Medical Action Industries is recalling 180 PICC/CVC Secure Dressing Change kits because the presence of CHG is not identified on the exterior labeling.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is misbranding (unlabeled CHG) and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Medical Action Industries, Inc. is recalling 9 cases (180 kits) of PICC/CVC Secure Dressing Change kits, Reference 73775, Lot 213403. These sterile, single-use kits are used by clinicians to change dressings. The recall is due to misbranding, as the kits contain CHG (chlorhexidine gluconate) which is not identified on the exterior labeling.

The affected products were distributed nationwide to Missouri, Nebraska, and Texas. The source text does not report any illnesses or injuries associated with this recall.

Consumers and healthcare facilities should stop using the affected kits and contact Medical Action Industries for further instructions or a return.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Kit #73775
  • Lot 213403

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: