Valleylab Laparoscopic Products (2016-07-08)

Starting date:

July 8, 2016

Posting date:

July 22, 2016

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-59494

• Reason
• Affected products

Affected products

1. VALLEYLAB LAPAROSCOPIC STRAIGHT SPATULA ELECTRODE
2. VALLEYLAB LAPAROSCOPIC CURVED SPATULA ELECTRODE
3. VALLEYLAB LAPAROSCOPIC WIRE J-HOOK ELECTRODE
4. VALLEYLAB LAPAROSCOPIC WIRE L-HOOK ELECTRODE
5. LAPAROSCOPIC FLAT L-HOOK ELECTRODE
6. LAPAROSCOPIC CYLINDRICAL TIP ELECTRODE
7. VALLEYLAB LAPAROSCOPIC ARGON BLADE
8. VALLEYLAB FLEXIBLE LAPAROSCOPIC ARGON ELECTRODE
9. VALLEYLAB FLEXIBLE ARGON ELECTRODE - COAGULATION
10. VALLEYLAB LAPAROSCOPIC ARGON MODIFIED FLAT L ELEC
11. VALLEYLAB LAPAROSCOPIC ARGON SHARP NEEDLE
12. VALLEYLAB LAPAROSCOPIC ARGON BLUNT NEEDLE ELECTRO

Reason

This voluntary recall is being conducted due to the potential for compromise of the package resulting in a breach of the sterile barrier. The use of products with this packaging defect may increase risk of infection. There have been no reports of serious injury associated with this issue (according to the manufacturer).

Affected products