Sterile Angiography Drapes Recalled Due to Sticking Plastic Film Defect
Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with no reported hospitalizations or injuries. The manufacturing defect prevents proper application of a protective surgical drape, constituting a risk-of-harm situation where injury has not yet been reported, meeting the rubric criteria for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes (Catalog Number 29529). The defect affects both angiography drape and cesarean birth drape products manufactured with the same plastic film.
The plastic film used in manufacturing is causing the drapes to stick, which may prevent the products from being unfolded and applied properly during surgical procedures. These drapes are intended to be used as protective patient coverings to isolate the surgical site from microbial and other contamination.
The affected lot numbers are: 20HGR063, 20JGR059, 20JGR068, 20JGR094, 20KGR048, and 20LGR074. The recalled products were distributed nationwide in the United States in both single sterile and bulk non-sterile configurations.
Healthcare facilities should immediately discontinue use of the affected lot numbers and contact Cardinal Health 200, LLC for return and replacement instructions.
The recalled product
- Product
- Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - 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
- Hazard
- Affected units
- 3,192
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 (6)
- Lot Numbers: 20HGR063
- 20JGR059
- 20JGR068
- 20JGR094
- 20KGR048
- 20LGR074
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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