CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Medline procedural kits labeled as recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedural kits labeled as: Carotid Endarterectomy PK, Pack Number. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2745-2024
- FDA event ID
- 94581
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 28 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 28 Aug 2024 | Classified by FDA | +142 days |
| 4 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
Where it was distributed
Worldwide
Questions about this recall
Is Medline procedural kits labeled as: Carotid Endarterectomy PK, Pack Number recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedural kits labeled as: Carotid Endarterectomy PK, Pack Number on 8 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2745-2024.
Why was it recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Which lots are affected?
DYNJ85516, Lot Number 23JBI659 ; DYNJ85516, Lot Number 23LBE170 ; DYNJ85516, Lot Number 23LBR472 ; PICCNC0004 , Lot Number 23JMG079 ; CVI4825, Lot Number 22FLA595 ; CVI4825, Lot Number 22JLA721 ; CVI4825, Lot Number 22JLB203 ; CVI4825, Lot Number 22KLA852
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MEDLINE INDUSTRIES, LP - Northfield
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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