Recall Z-2530-2015
Covidien LLC · initiated August 6, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 compatible intravenous administration sets and indwelling intravascular access devices.
Codes / lots: Lot Numbers: 1506200118
Reason for recall
Sterility may be compromised
FDA-determined cause: Packaging process control
Action taken
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
Details
- Recall number
- Z-2530-2015
- Initiated
- August 6, 2015
- Posted by FDA
- September 1, 2015
- Terminated
- June 29, 2017
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- 53 kits
- Distribution
- US Nationwide Distribution
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2525-2015 Class II | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage:…Sterility may be compromised | 08/06/2015Terminated |
| Z-2526-2015 Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2527-2015 Class II | Mahurkar Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2528-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC*…Sterility may be compromised | 08/06/2015Terminated |
| Z-2529-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2531-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2532-2015 Class II | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2533-2015 Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2534-2015 Class II | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety…Sterility may be compromised | 08/06/2015Terminated |
| Z-2535-2015 Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved…Sterility may be compromised | 08/06/2015Terminated |
| Z-2536-2015 Class II | MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved…Sterility may be compromised | 08/06/2015Terminated |
| Z-2537-2015 Class II | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight…Sterility may be compromised | 08/06/2015Terminated |