TEMED
Temed · Model P2524 · UDI-DI 05060660971503
9
510(k) clearances
243
Adverse events (3 deaths)
11
Recalls
24
Facilities
Description
TEMED Sucker Line The TEMED Suckers are single use, sterile devices that are intended for the extraction of bodily fluids and secretions, surgical tissue, debris and irrigation fluids from the surgical field into a filtered reservoir.
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. |
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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.