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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71893

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 06, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

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.

Z-2525-2015
Recall number
Z-2525-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
207,876

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: P15035 P15036 P15037 P15041 P15042 P15046 P15047 P15048 P15049 P15056 P15057 P15058 P15059 P15063 P15064 P15069 P15070 P15071 P15078 P15079 P15080 P15081 P15091

Distribution pattern

US Nationwide Distribution

device · product 2 of 13

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.

Z-2526-2015
Recall number
Z-2526-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
96 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1508200108

Distribution pattern

US Nationwide Distribution

device · product 3 of 13

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.

Z-2527-2015
Recall number
Z-2527-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
8 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1506500122

Distribution pattern

US Nationwide Distribution

device · product 4 of 13

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.

Z-2528-2015
Recall number
Z-2528-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
116 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1506200114; 1506900083

Distribution pattern

US Nationwide Distribution

device · product 5 of 13

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.

Z-2529-2015
Recall number
Z-2529-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
4 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1504000115

Distribution pattern

US Nationwide Distribution

device · product 6 of 13

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.

Z-2530-2015
Recall number
Z-2530-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
53 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1506200118

Distribution pattern

US Nationwide Distribution

device · product 7 of 13

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.

Z-2531-2015
Recall number
Z-2531-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
67 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1506200119 1511100102

Distribution pattern

US Nationwide Distribution

device · product 8 of 13

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.

Z-2532-2015
Recall number
Z-2532-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
1 kit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1505400155

Distribution pattern

US Nationwide Distribution

device · product 9 of 13

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.

Z-2533-2015
Recall number
Z-2533-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
165 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1504700136

Distribution pattern

US Nationwide Distribution

device · product 10 of 13

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.

Z-2534-2015
Recall number
Z-2534-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
171 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1504700138

Distribution pattern

US Nationwide Distribution

device · product 11 of 13

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.

Z-2535-2015
Recall number
Z-2535-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
569 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1504700146

Distribution pattern

US Nationwide Distribution

device · product 12 of 13

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.

Z-2536-2015
Recall number
Z-2536-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
325 KITS

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1508900109, 1507600095

Distribution pattern

US Nationwide Distribution

device · product 13 of 13

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.

Z-2537-2015
Recall number
Z-2537-2015
Initiated
August 06, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
550 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility may be compromised

Code information

Lot Numbers: 1504700147, 1507600096

Distribution pattern

US Nationwide Distribution