Home › GENESIS BPS LLC › Genesis RapidWeld II STW Sterile Tube Welder
Genesis RapidWeld II STW Sterile Tube Welder
GENESIS BPS LLC · Model GRW-430-02 · UDI-DI 00866305000264
KSB
Prescription
6
510(k) clearances
71
Adverse events (2 deaths)
11
Recalls
19
Facilities
Description
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
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.