The Recall Desk
ModerateFDA (Devices)·Z-3046-2017·Announced 2017-08-30

Cardinal Health Recalls Mispackaged Robotic Surgical Drapes

Cardinal Health 200, LLC is recalling 200 units of Robotic Drape with Leggings that were incorrectly packaged as LAVH drapes.

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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling/packaging error rather than a direct contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.

Plain-English summary

Cardinal Health 200, LLC is recalling 200 units of Convertors Robotic Drape with Attached Leggings. The product is packaged as a Single Sterile Drape, with 8 per case. The recall is due to a packaging error where the product was labeled as LAVH drape (Product 29474) instead of the correct Robotic Drape with Leggings (Product 29574).

The affected lot number is 17DAH349. The products were distributed in the United States to the states of North Carolina, Utah, Oregon, New York, Texas, Georgia, New Jersey, and Florida.

The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Affected units
200

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 (1)

  • Lot number 17DAH349

Distribution

Distributed in 8 states: