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.
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, 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 to
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drapes
- Hazard
- 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
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.
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