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Karl Storz GmbH & Co. KG · Model 031432-10 · UDI-DI 04048438003459

NKC Prescription
0
510(k) clearances
51
Adverse events
3
Recalls
94
Facilities

Description

Insufflation Tubing Set, with gas filter

Recalls

DateFirmReason
2019-01-09Karl Storz EndoscopyThe sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
2017-10-10Karl Storz EndoscopyThe label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
2013-07-15DeRoyal Industries IncDeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.