Recall events
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Event 71893
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2525-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55577]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24251]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2526-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14619]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17709]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2527-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55570]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17659]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2528-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[2833]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[25135]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2529-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8784]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23671]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2530-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[49866]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17706]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2531-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55589]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22245]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2532-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55571]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23776]
FDA event record
· Exact recall-number query on openFDA
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
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2533-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55565]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21859]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2534-2015
Initiated August 06, 2015
Classification Class II
Status Terminated
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2534-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[2839]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23773]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2535-2015
Initiated August 06, 2015
Classification Class II
Status Terminated
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2535-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32469]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21814]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2536-2015
Initiated August 06, 2015
Classification Class II
Status Terminated
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2536-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32464]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[25141]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2537-2015
Initiated August 06, 2015
Classification Class II
Status Terminated
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
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2537-2015
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55572]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24299]
FDA event record
· Exact recall-number query on openFDA