Theracath Spring Wire Epidural Catheter & Epidural Needle Kit (2020-07-08)
- Starting date:
- July 8, 2020
- Posting date:
- July 17, 2020
- 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-73557
Last updated: 2020-07-17
Affected Products
- Theracath Spring Wire Epidural Catheter
- Epidural Needle Kit
Reason
The product lidstock contains a labelling error. The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Affected products
-
Theracath Spring Wire Epidural Catheter
Lot or serial number
13F18C0518
Model or catalog number
EC-05000
Companies
- Manufacturer
-
ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED
3015 CARRINGTON MILL BLVD.
MORRISVILLE,
27560
North Carolina
UNITED STATES
B. Epidural Needle Kit
Lot or serial number
13F17J0230
Model or catalog number
AK-03000-S
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES