FDASeptember 23, 2015device
Ventilator Tubing
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the potential for delamination to occur between the layers of the tube wall which, should it occur, would result in leakage
What to do
FDA enforcement status: Terminated
Brands named
instrumentation
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGEM Premier 5000; Part No. 00055415010.2026-01-20
- FDAGEM Premier 5000; Part No. 00055415005.2026-01-20
- FDAGEM Premier 5000; Part No. 00055415008.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407504.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407508.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407511.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407510.2026-01-20
- FDAGEM Premier 5000; Part No. 00055430004.2026-01-20
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