Health product recall

PneumoSure High Flow Insufflator - High Flow II Tube Set, Heated Tube Set with RTP (2019-03-07)

Starting date:
March 7, 2019
Posting date:
March 28, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Identification number:
RA-69424

Affected Products

A. PneumoSure High Flow Insufflator - High Flow II Tube Set
B. PneumoSure High Flow Insufflator - Heated Tube Set with RTP

Reason

It was reported via customer complaint that the tube set can potentially detach from the cassette.

Affected products

A. PneumoSure High Flow Insufflator - High Flow II Tube Set

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

620040660

Companies
Manufacturer

Stryker Endoscopy

5900 Optical Court

San Jose

95138

California

UNITED STATES

B. PneumoSure High Flow Insufflator - Heated Tube Set with RTP

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

0620-040-690
620-040-680

Companies
Manufacturer

Stryker Endoscopy

5900 Optical Court

San Jose

95138

California

UNITED STATES