Health product recall

Cardinal Healths' Sterile Obstetrical Pack, Pack Prostate Rad and Pack Uteroscopy (2018-04-24)

Starting date:
April 24, 2018
Posting date:
May 18, 2018
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-66800

Affected products

A. Sterile Obstetrical Pack
B. Pack Prostate Rad
C. Pack Uteroscopy

Reason

Recall was initiated due to the expiry of a component used in the manufacturing of Cardinal Health Presource Kits. All other components contained within the kits are still within valid expiry. The expired lots of the indicated kits are to be reworked with a warning label indicating which component has expired and instructing the physician to dispose of the component at time of use, replacing it with non-expired stock from their inventory. The label will also indicate what the updated expiry of the kit is, advanced to the next component expiry date.

Affected products

A. Sterile Obstetrical Pack

Lot or serial number

670921

Model or catalog number

SMA30CSLG8

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

B. Pack Prostate Rad

Lot or serial number

738744

Model or catalog number

SOT30PRALJ

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

C. Pack Uteroscopy

Lot or serial number

564798

Model or catalog number

SOT30UPCCB

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES