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Level 1
ICU MEDICAL, INC. · Model MTS-TC15 · UDI-DI 30695085000536
DTW
Prescription
1
510(k) clearances
153
Adverse events
15
Recalls
6
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-01-12 | Terumo Cardiovascular Systems Corp | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran |
| 2007-01-12 | Terumo Cardiovascular Systems Corp | The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cran |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
| 2006-09-14 | Terumo Cardiovascular Systems Corp | The hand crank handle may separate and detach from the unit during use. |
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Get your free API keyRead the docsData 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.