CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Medline procedure packs containing Shenli syringes recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure packs containing Shenli syringes, labeled as follows: Cvc Insert Bundle. 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-2629-2024
- FDA event ID
- 94582
- 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
- Syringes & Needles
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 procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Medline procedure packs containing Shenli syringes, labeled as follows: Cvc Insert Bundle recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure packs containing Shenli syringes, labeled as follows: Cvc Insert Bundle on 8 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2629-2024.
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?
1) ECVC3260, Lot Number 2018052950; 2) ECVC8045, Lot Number 2023110290
Where was it sold?
Worldwide distribution.
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.
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| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
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