Cardinal Health™ Clear Leggings and Angiographic Drapes (2021-05-20)

Starting date:
May 20, 2021
Posting date:
May 26, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75655

Last updated:

Affected Products 

  1. In-View Clear Leggings Sterile
  2. Femoral Angiography Drape Sterile
  3. Sterile Femoral Angiography Drape with Single Pouch
  4. Sterile Radial/Femoral Angiography Drape
  5. Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen
  6. Sterile Femoral Angiography Drape

Reason

Cardinal Health had previously notified customers in February of a Medical Device Recall for certain production lots of Cardinal Health Clear Leggings and Angiographic Drapes because Cardinal has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the Drapes and Leggings to "stick", which may prevent the products from being unfolded and applied properly. Cardinal Jealth is expanding the previous market action to include additional skus and lots of Angiography Drapes and Cesarean Birth Drapes.

Affected products

A. In-View Clear Leggings Sterile

Lot or serial number
  • 20JKS003
  • 20JKS004
  • 20JKS005
  • 20KKS047
  • 20KKS050
  • 20LKS063
  • 20LKS075
  • 20MKS003
Model or catalog number
  • A8430
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

B. Femoral Angiography Drape Sterile

Lot or serial number
  • 20LQR067
  • 20MQR023
Model or catalog number
  • A29560
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

C. Sterile Femoral Angiography Drape with Single Pouch

Lot or serial number
  • 20LJS033
  • 20MJS072
Model or catalog number
  • A29525
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

D. Sterile Radial/Femoral Angiography Drape

Lot or serial number
  • 20HGR063
  • 20JGR059
  • 20JGR068
  • 20JGR094
  • 20KGR048
  • 20LGR074
Model or catalog number
  • A29529
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

E. Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen

Lot or serial number
  • 20LRR092
  • 20MRR079
Model or catalog number
  • A29442
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

F. Sterile Femoral Angiography Drape

Lot or serial number
  • 20LRS055
  • 20MMR062
  • 20MRS073
  • 21ARS042
  • 21ARS056
Model or catalog number
  • A29456
  • A29456CE
  • A29460
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES