Reported May 20, 2020 · Terminated
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Karl Storz Endoscopy
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
- Lot codes and dates
4 of 4 products · 11 lot codes
Recalled lot codes, grouped by product number Model Lot Number 031200-10Lot W-027781W-029058W-028738
031322-10Lot W-027197W-028171W-027939W-028207
031532-10Lot W-026437W-027332W-026871
031622-10Lot W-029555
- Amount recalled
- 543 boxes were distributed; 10 ea per box.
Where it was sold
Why it was recalled
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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