Recall Z-0442-2022— Karl Storz Endoscopy
Class II · Ongoing
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2021-10-15. It names one FDA 510(k) clearance: K201945. Product: Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES). Reason: To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-15
- Firm location
- El Segundo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)
Reason for recall
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.
Data sourced from openFDA. This site is unofficial and independent of the FDA.