510(k) K060339 ยท NGT Saline, Vascular Access Flush
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
| Applicant | Tyco Healthcare/Kendall, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 28, 2006 |
| Received | Feb 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2015 | Covidien LLC Monoject 0.9% Saline Flush Prefill Double Pouch
Item Code: 8881570129
Product Usage:
Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intrav Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm
Item Code: 8888135137
Product Usage:
Sterile Delivery are indicated for use in fl Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm
Item Code: 8888135139
Product Usage:
Sterile Delivery are indicated for use in flushing com Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm
Item Code: 8888211424
Product Usage:
Sterile Delivery are indicated for use Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm
Item Code: 8888213420
Product Usage:
Sterile Delivery are indicated for use in flushin Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm
Item Code:8888221420
Product Usage:
Sterile Delivery are indicated for use in flushing co Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm
Item Code: 8888222416
Product Usage:
Sterile Delivery are indicated for use in flushing com Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm
Item Code: 8888233413
Product Usage:
Sterile Delivery are indicated for use in flushing Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm
Item Code: 8888233420
Product Usage:
Sterile Delivery are indicated for use in flushing Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray
Item Code: 8888103002HP
Product Usage:
Sterile Delivery are indicated for use in flushing compatib Terminated |
NGT | None listed |
| Sep 1, 2015 | Covidien LLC MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray
Item Code: 8888103003HP
Product Usage:
Sterile Delivery are indicated for use in flushing comp Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.