Health product recall

Bifurcated Insufflation Tubing & Insufflation Tubing (2020-01-13)

Starting date:
January 13, 2020
Posting date:
February 7, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72259

Last updated: 2020-02-07

Affected Products

A. Bifurcated Insufflation Tubing
B. Insufflation Tubing

Reason

It is suspected that the affected products had increased residues of the sterilization gas ethylene oxide (EO) at the time of delivery because a validation parameter (temperature during outgassing) had not been monitored.

Affected products

  1. Bifurcated Insufflation Tubing

Lot or serial number

W-026437
W-026871
W-027332
W-029555

Model or catalog number

031532-10
031622-10

Companies
Manufacturer

KARL STORZ SE & CO. KG

DR.-KARL-STORZ STRASSE 34

TUTTLINGEN

78532

GERMANY

B. Insufflation Tubing

Lot or serial number

W-027781
W-028738
W-029058
W-027197
W-027939
W-028171
W0028207

Model or catalog number

031200-10
031322-10

Companies
Manufacturer

KARL STORZ SE & CO. KG

DR.-KARL-STORZ STRASSE 34

TUTTLINGEN

78532

GERMANY