The Recall Desk
HighFDA (Devices)·Z-2033-2021·Announced 2021-07-14

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.

What this means for you

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
Category
Medical Device — Surgical Drape / Protective Covering
Hazard
  • sticking
  • malfunction

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.

Related recalls

Same category