Medline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for medical device defects. The source text identifies no reported illnesses or injuries. Per the rubric, product recalls with risk of harm where injury has not yet been reported score at the 'High' level.
Plain-English summary
Medline Industries, LP is recalling Centurion procedure kits containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits include CVC INSERT BUNDLE 16CM (Pack Number ECVC3260) and CVC DOUBLE LUMEN 16CM (Pack Number ECVC8105). The syringes may leak, break, or exhibit other quality defects that pose a risk to patient health.
These procedure kits have been distributed worldwide. The lot numbers affected are 2021031650 and 2023012490.
The recalled product
- Product
- Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Hazard
- syringe-leak
- syringe-breakage
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) ECVC3260
- Lot Number 2021031650
- 2) ECVC8105
- Lot Number 2023012490
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27