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K-Shield Advantage Blood Drawing Kit
SB-KAWASUMI LABORATORIES, INC. · Model BK-64A · UDI-DI 00646311630040
KSB
Prescription
6
510(k) clearances
71
Adverse events (2 deaths)
11
Recalls
19
Facilities
Description
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
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 |
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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.