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
- Nelaton Catheter - PVC
- Catheters for Women - PVC
- 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