Food, drugs, devices › Covidien LLC
Device recall: Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for
FDA enforcement event 71893 is a device recall by Covidien LLC of North Haven, CT, initiated 6 Aug 2015 and classified Class II, with 13 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 29 Jun 2017. Initiation: voluntary: firm initiated. Covidien LLC has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien LLC, North Haven, CT.
Reason for recall
"Sterility may be compromised"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2525-2015 | 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 intravascular access devices. | 207,876 | Class II | Terminated | 9 Sep 2015 |
| Z-2526-2015 | 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 flushing compatible intravenous administration sets and indwelling intravascular access devices. | 96 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2527-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 8 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2528-2015 | 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 in flushing compatible intravenous administration sets and indwelling intravascular access devices. | 116 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2529-2015 | 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 flushing compatible intravenous administration sets and indwelling intravascular access devices. | 4 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2530-2015 | 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. | 53 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2531-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 67 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2532-2015 | Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. | 1 kit | Class II | Terminated | 9 Sep 2015 |
| Z-2533-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 165 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2534-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 171 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2535-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 569 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2536-2015 | 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 compatible intravenous administration sets and indwelling intravascular access devices. | 325 KITS | Class II | Terminated | 9 Sep 2015 |
| Z-2537-2015 | MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. | 550 kits | Class II | Terminated | 9 Sep 2015 |
Context
Other enforcement events for Covidien LLC
All 77 events for Covidien LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Sterility may be compromised"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Jun 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.