The Recall Desk
ModerateFDA (Devices)·Z-1611-2022·Announced 2022-08-31

IV Securement Kit Recall Due to Storage Temperature Damage

McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.

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 addresses potential product degradation from storage temperature excursions. No illnesses or injuries have been reported and the hazard is theoretical, placing this at Moderate severity per FDA rubric criteria.

Plain-English summary

Medline Industries Centurion IV Securement Kit (Model IVSSTK3) is being recalled due to potential damage from temperature exposure. The recall affects all lots received between June 1, 2021 and September 30, 2021.

From June through August 2021, prior to delivery, the product was exposed to higher temperatures that may have impacted its ability to effectively secure intravenous lines. The affected product was distributed nationwide.

Healthcare facilities and providers who received affected lots should contact McKesson Medical-Surgical Inc. for further instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-excursion
  • reduced-effectiveness

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)

  • GTIN: 10653160244950 EA
  • 00653160244953 CS

Distribution

Distributed nationwide across the United States.