Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2758-2017·Announced 2017-08-02

Cardinal Health Recalls Tiburon Arthroscopy Drapes Due to Labeling Mismatch

Cardinal Health is recalling specific lots of Tiburon Arthroscopy Drapes because the outer labels do not match the packaged product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 no illnesses or injuries are reported and the hazard is a labeling mismatch, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health 200, LLC is recalling 528 units of Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1. The recall affects Lot 16LUS317, which expires on November 1, 2021. The product was distributed nationwide in the United States, including Puerto Rico, and in Canada.

The recall was initiated because the outer label of some units does not match the drape packaged inside. This discrepancy involves product number/lot number 9414, Lot 16LUS317, as well as product number/lot number 8482, Lot 16LFS235. The source text does not report any illnesses or injuries associated with this recall.

Healthcare facilities and consumers should check their inventory for the specific lot numbers and product references listed in this notice. If the product is found, it should be removed from use and returned to the supplier or Cardinal Health for credit or replacement.

The recalled product

Product: Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drapes
Hazard: mis-labeling
Affected units: 528

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 (3)

Lot 16LUS317
expires November 1
2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · mis labeling