Health product recall

ConvaTec's Nelaton Catheter - PVC, Catheters for Women - PVC, Tiemann Catheters - PVC (2018-12-04)

Starting date:
December 4, 2018
Posting date:
January 23, 2019
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-68826

Affected products

  1. Nelaton Catheter - PVC
  2. Catheters for Women - PVC
  3. Tiemann Catheters - PVC

Reason

Internal assessment of product packaging integrity has confirmed that these devices are not meeting the expectations. Transportation testing conducted to the product packaging failed confirming the potential for a breach in the sterile barrier. Using a non-sterile device on a patient may expose the patient to infectious agents increasing the patient risk of developing infection.

Affected products

A. Nelaton Catheter - PVC

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 01001182
  • 01004182
  • 01007182
  • 01008182
  • 01009182
  • 01013182
  • 01015182
  • 01017182
  • 01019182
  • 01020182
Companies
Manufacturer

ConvaTec Inc.

7900 Triad Center Drive, Suite # 400

Greensboro

27409

North Carolina

UNITED STATES


B. Catheters for Women - PVC

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 02012182
  • 02014182
  • 02015182
  • 02016182
  • 02017182
  • 02019182
  • 02020182
Companies
Manufacturer

ConvaTec Inc.

7900 Triad Center Drive, Suite # 400

Greensboro

27409

North Carolina

UNITED STATES


C. Tiemann Catheters - PVC

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 03005182
  • 03006182
  • 03007182
  • 03008182
  • 03009182
  • 03011182
  • 03013182
  • 03014182
Companies
Manufacturer

ConvaTec Inc.

7900 Triad Center Drive, Suite # 400

Greensboro

27409

North Carolina

UNITED STATES