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Disposable Hemodialysis Access Catheter Set
Guangdong Baihe Medical Technology Co., Ltd. · Model Single Lumen7F*16cm · UDI-DI 06938634472044
1
510(k) clearances
3,212
Adverse events (73 deaths)
22
Recalls
40
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-29 | Mozarc Medical US LLC | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
| 2018-07-12 | Medical Components, Inc dba MedComp | The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 br |
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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.