Reported Jan 5, 2022 · Ongoing
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD,…
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
20 of 20 products · 35 lot codes
| Tray Part Number | Description |
|---|---|
39301ACTS |
|
39301AS |
|
39301BCTS |
|
39301BS |
|
39301C1S |
|
39301CS |
|
39301DS |
|
39301HCTS |
|
39301PHTS |
|
39305C1S |
|
- Lot codes and dates
- All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
- Amount recalled
- 71892
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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