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
-
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