Recall Z-1942-2020— Karl Storz Endoscopy
Class III · Terminated
Class III FDA medical device recall by Karl Storz Endoscopy, initiated 2019-01-09, terminated 2022-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10. Reason: The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-01-09
- Terminated
- 2022-09-28
- Firm location
- El Segundo, CA, United States
Product description
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Reason for recall
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Data sourced from openFDA. This site is unofficial and independent of the FDA.