PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported September 18, 2024

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC

XXX

Recall #
Z-2995-2024
Initiated
April 8, 2024
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Medline Industries, LP - Northfield recalled Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) … - a moderate-severity action.

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) … was recalled by Medline Industries, LP - Northfield in September 18, 2024. Reason: XXX. Check the official notice for the remedy. Verify recall #Z-2995-2024 with the FDA Devices before acting.

The recall

Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-XXX.

Moderate
severity level
Class II
classification
September 18, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2995-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC-MLD, Pack Number 00-500510D ; 11) ADVANTEC-MLD, Pack Number 00-500510F ; 12) KIT ANGIO CSTM-WALKER, Pack Number 129969; 13) DIAGNOSTIC KIT, Pack Number 147943; 14) MSC - CRESCENT MEDICAL, Pack Number 149155; 15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111; 16) OPEN HEART CDS, Pack Number CDS840015AK; 17) OPEN HEART CDS, Pack Number CDS840015AL; 18) OPEN HEART CDS, Pack Number CDS840015AM; 19) OPEN HEART CDS, Pack Number CDS840015AN; 20) OPEN HEART CDS, Pack Number CDS840015AO; 21) OPEN HEART CDS, Pack Number CDS840015AP; 22) OPEN HEART CDS, Pack Number CDS840015AQ; 23) OPEN HEART CDS, Pack Number CDS840015AQ; 24) OPEN HEART CDS, Pack Number CDS840016AD; 25) OPEN HEART CDS, Pack Number CDS840016AD; 26) OPEN HEART CDS, Pack Number CDS840023R ; 27) OPEN HEART CDS, Pack Number CDS840023S ; 28) OPEN HEART CDS, Pack Number CDS840023T ; 29) AAA CDS , Pack Number CDS840076AC; 30) OFF PUMP CABG CDS , Pack Number CDS840087AB; 31) OFF PUMP CABG CDS , Pack Number CDS840087AD; 32) OFF PUMP CABG CDS , Pack Number CDS840087AF; 33) OFF PUMP CABG CDS , Pack Number CDS840087AG; 34) OFF PUMP CABG CDS , Pack Number CDS840087AI; 35) OFF PUMP CABG CDS , Pack Number CDS840087AJ; 36) OFF PUMP CABG CDS , Pack Number CDS840087AK; 37) OFF PUMP CABG CDS , Pack Number CDS840087AL; 38) OPEN HEART CDS, Pack Number CDS840094L ; 39) OPEN HEART CDS, Pack Number CDS840094M ; 40) OPEN HEART CDS, Pack Number CDS840094N ; 41) OPEN HEART CDS, Pack Number CDS840094P ; 42) OPEN HEART CDS, Pack Number CDS840108J ; 43) OPEN HEART CDS, Pack Number CDS840108K ; 44) OPEN HEART CDS, Pack Number CDS840132N ; 45) OPEN HEART CDS, Pack Number CDS840132O ; 46) OPEN HEART CDS, Pack Number CDS840144O ; 47) OPEN HEART CDS, Pack Number CDS840144P ; 48) OPEN HEART CDS, Pack Number CDS840144Q ; 49) OPEN HEART CDS, Pack Number CDS840144Q ; 50) OPEN HEART CDS, Pack Number CDS840145S ; 51) OPEN HEART CDS, Pack Number CDS840145T ; 52) OPEN HEART CDS, Pack Number CDS840145U ; 53) OPEN HEART, Pack Number CDS840150R ; 54) OPEN HEART, Pack Number CDS840150S ; 55) OPEN HEART, Pack Number CDS840150T ; 56) OPEN HEART, Pack Number CDS840150U ; 57) OPEN HEART, Pack Number CDS840150V ; 58) PACEMAKER CDS , Pack Number CDS840162S ; 59) PACEMAKER CDS , Pack Number CDS840162T ; 60) PACEMAKER CDS , Pack Number CDS840162U ; 61) PACEMAKER CDS , Pack Number CDS840162V ; 62) OPEN HEART CDS, Pack Number CDS840171AA; 63) OPEN HEART CDS, Pack Number CDS840171AB; 64) OPEN HEART CDS, Pack Number CDS840171AC; 65) OPEN HEART CDS, Pack Number CDS840171AD; 66) HEART CDS , Pack Number CDS840179M ; 67) HEART CDS, Pack Number CDS840179M ; 68) MINOR VASCULAR PACK , Pack Number CDS840184M ; 69) MINOR VASCULAR PACK , Pack Number CDS840184N ; 70) MINOR VASCULAR PACK , Pack Number CDS840184O ; 71) MINOR VASCULAR PACK, Pack Number CDS840184P; 72) OPEN HEART PACK , Pack Number CDS840185S ; 73) OPEN HEART PACK , Pack Number CDS840185T ; 74) OPEN HEART PACK , Pack Number CDS840185U ; 75) OPEN HEART PACK , Pack Number CDS840185V ; 76) OPEN HEART PACK , Pack Number CDS840185W ; 77) VALVE PACK, Pack Number CDS840187S ; 78) VALVE PACK, Pack Number CDS840187T ; 79) OPEN HEART, Pack Number CDS840189R ; 80) MAJOR VASCULAR, Pack Number CDS840195T ; 81) MAJOR VASCULAR, Pack Number CDS840195U ; 82) CABG-LF , Pack Number CDS840231Q ; 83) CABG-LF , Pack Number CDS840231R ; 84) CABG-LF , Pack Number CDS840231S ; 85) CABG-LF , Pack Number CDS840231T ; 86) MAJOR VASCU

Reason for recall

XXX

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-2995-2024
Date reported September 18, 2024
Date initiated April 8, 2024
Recalling firm Medline Industries, LP - Northfield
Firm location Northfield, IL
Affected scope Not disclosed
Distribution Worldwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2995-2024) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC-MLD, Pack Number 00-500510D ; 11) ADVANTEC-MLD, Pack Number 00-500510F ; 12) KIT ANGIO CSTM-WALKER, Pack Number 129969; 13) DIAGNOSTIC KIT, Pack Number 147943; 14) MSC - CRESCENT MEDICAL, Pack Number 149155; 15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111; 16) OPEN HEART CDS, Pack Number CDS840015AK; 17) OPEN HEART CDS, Pack Number CDS840015AL; 18) OPEN HEART CDS, Pack Number CDS840015AM; 19) OPEN HEART CDS, Pack Number CDS840015AN; 20) OPEN HEART CDS, Pack Number CDS840015AO; 21) OPEN HEART CDS, Pack Number CDS840015AP; 22) OPEN HEART CDS, Pack Number CDS840015AQ; 23) OPEN HEART CDS, Pack Number CDS840015AQ; 24) OPEN HEART CDS, Pack Number CDS840016AD; 25) OPEN HEART CDS, Pack Number CDS840016AD; 26) OPEN HEART CDS, Pack Number CDS840023R ; 27) OPEN HEART CDS, Pack Number CDS840023S ; 28) OPEN HEART CDS, Pack Number CDS840023T ; 29) AAA CDS , Pack Number CDS840076AC; 30) OFF PUMP CABG CDS , Pack Number CDS840087AB; 31) OFF PUMP CABG CDS , Pack Number CDS840087AD; 32) OFF PUMP CABG CDS , Pack Number CDS840087AF; 33) OFF PUMP CABG CDS , Pack Number CDS840087AG; 34) OFF PUMP CABG CDS , Pack Number CDS840087AI; 35) OFF PUMP CABG CDS , Pack Number CDS840087AJ; 36) OFF PUMP CABG CDS , Pack Number CDS840087AK; 37) OFF PUMP CABG CDS , Pack Number CDS840087AL; 38) OPEN HEART CDS, Pack Number CDS840094L ; 39) OPEN HEART CDS, Pack Number CDS840094M ; 40) OPEN HEART CDS, Pack Number CDS840094N ; 41) OPEN HEART CDS, Pack Number CDS840094P ; 42) OPEN HEART CDS, Pack Number CDS840108J ; 43) OPEN HEART CDS, Pack Number CDS840108K ; 44) OPEN HEART CDS, Pack Number CDS840132N ; 45) OPEN HEART CDS, Pack Number CDS840132O ; 46) OPEN HEART CDS, Pack Number CDS840144O ; 47) OPEN HEART CDS, Pack Number CDS840144P ; 48) OPEN HEART CDS, Pack Number CDS840144Q ; 49) OPEN HEART CDS, Pack Number CDS840144Q ; 50) OPEN HEART CDS, Pack Number CDS840145S ; 51) OPEN HEART CDS, Pack Number CDS840145T ; 52) OPEN HEART CDS, Pack Number CDS840145U ; 53) OPEN HEART, Pack Number CDS840150R ; 54) OPEN HEART, Pack Number CDS840150S ; 55) OPEN HEART, Pack Number CDS840150T ; 56) OPEN HEART, Pack Number CDS840150U ; 57) OPEN HEART, Pack Number CDS840150V ; 58) PACEMAKER CDS , Pack Number CDS840162S ; 59) PACEMAKER CDS , Pack Number CDS840162T ; 60) PACEMAKER CDS , Pack Number CDS840162U ; 61) PACEMAKER CDS , Pack Number CDS840162V ; 62) OPEN HEART CDS, Pack Number CDS840171AA; 63) OPEN HEART CDS, Pack Number CDS840171AB; 64) OPEN HEART CDS, Pack Number CDS840171AC; 65) OPEN HEART CDS, Pack Number CDS840171AD; 66) HEART CDS , Pack Number CDS840179M ; 67) HEART CDS, Pack Number CDS840179M ; 68) MINOR VASCULAR PACK , Pack Number CDS840184M ; 69) MINOR VASCULAR PACK , Pack Number CDS840184N ; 70) MINOR VASCULAR PACK , Pack Number CDS840184O ; 71) MINOR VASCULAR PACK, Pack Number CDS840184P; 72) OPEN HEART PACK , Pack Number CDS840185S ; 73) OPEN HEART PACK , Pack Number CDS840185T ; 74) OPEN HEART PACK , Pack Number CDS840185U ; 75) OPEN HEART PACK , Pack Number CDS840185V ; 76) OPEN HEART PACK , Pack Number CDS840185W ; 77) VALVE PACK, Pack Number CDS840187S ; 78) VALVE PACK, Pack Number CDS840187T ; 79) OPEN HEART, Pack Number CDS840189R ; 80) MAJOR VASCULAR, Pack Number CDS840195T ; 81) MAJOR VASCULAR, Pack Number CDS840195U ; 82) CABG-LF , Pack Number CDS840231Q ; 83) CABG-LF , Pack Number CDS840231R ; 84) CABG-LF , Pack Number CDS840231S ; 85) CABG-LF , Pack Number CDS840231T ; 86) MAJOR VASCU. Recalled by Medline Industries, LP - Northfield.
Why was this product recalled? ▼
XXX
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-2995-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Methodology · Corrections · Archive as of August 2026