Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.
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 of medical procedure kits with identified syringe defects (leaks and breakage). No injuries or hospitalizations are reported in the source text; this is a risk-of-harm product where injury has not yet been reported, fitting the rubric's High (Score 3) category.
Plain-English summary
Medline Industries, LP is recalling multiple Centurion medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The recall includes over 80 different procedure kit models, such as radial and femoral arterial line kits, PICC line trays, biopsy trays, laceration trays, and other sterile procedure kits.
The plastic syringes in the affected kits have exhibited leaks, breakage, and other quality issues. These defects may pose a risk to patient health.
The affected kits were distributed worldwide. Specific lot numbers spanning from 2018 through 2024 are included in this recall.
Patients and healthcare providers should discontinue use of the affected kits immediately. Healthcare facilities should check their inventory against the provided lot numbers and contact Medline Industries for guidance on product return or safe disposal.
The recalled product
- Product
- Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Numbe
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- syringe-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 (20)
- ART240B
- Lot Number 2023083190
- PICC0020
- Lot Number 2023122290
- ART245B
- Lot Number 2023020990
- Lot Number 2023071090
- SUT15940
- Lot Number 2021070290
- Lot Number 2022090190
- Lot Number 2022092690
- SPEC0004C
- Lot Number 2019042990
- DYNDH1134
- Lot Number 2020032050
- SPEC0400
- Lot Number 2021120990
- Lot Number 2023050390
- PT220
- Lot Number 2018082290
Distribution
Distribution scope not specified by the agency.
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