Health product recall

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

  1. Theracath Spring Wire Epidural Catheter
  2. 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

  1. 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