Health product recall

Epidural Catheterization Kit (2020-01-17)

Starting date:
January 17, 2020
Posting date:
January 31, 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-72229

Last updated: 2020-01-31

Affected Products

  1. Epidural Catheterization Set
  2. Epidural Catheterization Kit
  3. Loss of Resistance Syringe

Reason

Arrow international, a subsidiary of Teleflex, is recalling the devices due to receipt of complaints reporting various failures with the LOR (loss of resistance) syringes resulting in dural puncture with some also requiring a blood patch.

Failures may present as follows:

  • the syringe may leak which could lead to a false positive result,
  • i.e. the clinician will think they have reached the epidural space before they do reach it.

The syringe may be blocked/sticking which may lead to a false negative result, as it would be possible to enter the epidural space with the epidural needle and be unaware of having done so because there would be no loss of resistance. In the latter setting, it would be possible to enter the subarachnoid space unknowingly, risking injury to nerves. This potential harm is also highly dependent on the level at which the procedure is performed. When performed for the relief of pain during labor and delivery, the procedure is ordinarily performed below the level of termination of the spinal cord, whereas if performed for the purpose of providing epidural analgesia following thoracic surgery for example, there is the risk of spinal cord injury.

Affected products

A. Epidural Catheterization Set

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • ASK-05400-CA1
  • ASK-17019-MSC
  • JC-05400-DCS
  • JC-05400-E
  • MP-17019-TIP
Companies
Manufacturer

Arrow International Inc.

2400 Bernville Road

Reading

19605

Pennsylvania

UNITED STATES

B. Epidural Catheterization Kit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • AJ-05500
  • ASK-02220-SRH
  • CA-02220
  • UR-05501
  • YC-02220
Companies
Manufacturer

Arrow International Inc.

2400 Bernville Road

Reading

19605

Pennsylvania

UNITED STATES

C. Loss of Resistance Syringe

Lot or serial number
  • 13F18J0916
  • 13F18K0675
  • 13F18L0737
  • 13F18M0178
  • 13F19C0321
  • 13F19D0335
  • 13F19E0212
Model or catalog number

LR-05501

Companies
Manufacturer

Arrow International Inc.

2400 Bernville Road

Reading

19605

Pennsylvania

UNITED STATES