Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Reported: May 20, 2020 Initiated: January 9, 2019 #Z-1942-2020
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.
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- 543 boxes were distributed; 10 ea per box.
- Distribution
- 57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10. Recalled by Karl Storz Endoscopy. Units affected: 543 boxes were distributed; 10 ea per box..
Why was this product recalled? ▼
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Low. Recall number: Z-1942-2020.
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