Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect
Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.
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 medical device recall with no reported illnesses or injuries. The manufacturing defect prevents proper application of a surgical protective device, creating a risk of harm to sterile field integrity. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Cardinal Health 200, LLC is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N, distributed nationwide in the United States. The drapes are protective patient coverings intended to isolate surgical incision sites from microbial and other contamination during radial and femoral angiography procedures.
The plastic film used to manufacture these drapes is causing them to stick, which may prevent the products from being unfolded and applied properly during use. This defect affects the drape's ability to function as intended in surgical settings.
The recall affects 23 specific lot numbers: 2320DR1, 2330DR1, 2410DR1, 2440DR1, 2450DR1, 2580DR1, 2670DR1, 2730DR1, 2740DR1, 2790DR1, 2830DR1, 2860DR1, 2870DR1, 2890DR1, 2900DR1, 2930DR1, 2940DR1, 2950DR1, 3080DR1, 3310DR1, 3320DR1, 3330DR1, and 3350DR1. The drapes were sold in both single sterile and bulk non-sterile configurations.
Healthcare facilities and distributors in possession of affected products should discontinue use and contact Cardinal Health for instructions on returns or replacements. Patients who may have received these drapes during procedures should consult their healthcare provider with any concerns.
The recalled product
- Product
- Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - 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
- 13,426
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 (20)
- Lot Numbers: 2320DR1
- 2330DR1
- 2410DR1
- 2440DR1
- 2450DR1
- 2580DR1
- 2670DR1
- 2730DR1
- 2740DR1
- 2790DR1
- 2830DR1
- 2860DR1
- 2870DR1
- 2890DR1
- 2900DR1
- 2930DR1
- 2940DR1
- 2950DR1
- 3080DR1
- 3310DR1
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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