Home › SORIN GROUP ITALIA SRL › Suction tip
Suction tip
SORIN GROUP ITALIA SRL · Model SU-22702 · UDI-DI 08033178018739
DTS
Prescription
9
510(k) clearances
243
Adverse events (3 deaths)
11
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-19 | Medtronic Perfusion Systems | Potential for unsealed sterile packing. |
| 2015-08-07 | International Biophysics Corp. | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
| 2012-11-02 | California Medical Laboratories Inc | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come l |
| 2012-11-02 | California Medical Laboratories Inc | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come l |
| 2011-10-05 | International Biophysics Corp | Potential for the sterility to be compromised. |
| 2011-09-13 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. |
| 2011-09-13 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker. |
| 2008-02-05 | Terumo Cardiovascular Systems Corporation | A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient. |
| 2008-01-24 | California Medical Laboratories Inc | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
| 2008-01-24 | California Medical Laboratories Inc | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.