Sterile Femoral Angiography Drape Sticks; Cannot Unfold Properly
Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.
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: FDA Class II recall with no reported illnesses or injuries. The defect is functional rather than involving a direct health hazard, representing a precautionary quality-control recall before any adverse outcome has occurred.
Plain-English summary
Cardinal Health 200, LLC is recalling 574 units of Sterile Femoral Angiography Drape with Single Pouch (Catalog Number 29525). The plastic film used to manufacture these drapes is causing them to stick, which may prevent the products from being unfolded and applied properly. The affected drapes were distributed nationwide and include lot numbers 20LJS033 and 20MJS072.
These drapes are intended to be used as protective patient coverings to isolate surgical incision sites from microbial and other contamination. Healthcare facilities and professionals who have received these drapes should stop using them immediately and contact Cardinal Health 200, LLC for replacement units.
The recalled product
- Product
- Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drape
- Affected units
- 574
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)
- Lot Numbers: 20LJS033
- 20MJS072
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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Similar recalls
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