Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2757-2017·Announced 2017-08-02

Cardinal Health Recalls Mislabeled Sterile Surgical Drapes

Cardinal Health is recalling specific lots of sterile surgical drapes because the outer labels do not match the packaged product inside.

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, and the source text describes a labeling mismatch without reporting any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health 200, LLC is recalling 1,591 units of Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1. The recall affects Lot 16LFS235, which expires on November 1, 2021. The product is a sterile surgical drape intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination.

The recall was initiated because the outer label of some units does not match the drape packaged inside. This labeling discrepancy affects product number/lot number 8482, Lot 16LFS235, and product number/lot number 9414, Lot 16LUS317. The affected units were distributed nationwide in the United States, including Puerto Rico, and in Canada.

Healthcare facilities and consumers should check their inventory for the specific lot numbers and product numbers listed in this recall. If these products are found, they should be removed from use and returned to the supplier or Cardinal Health for further instructions.

The recalled product

Product: Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, 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…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drapes
Hazard: mis-labeling
Affected units: 1,591

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 16LFS235
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