Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are 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: This is an FDA Class II recall of medical device syringes with identified quality defects (leaks and breakage). No illnesses or injuries have been reported. Per the rubric, Class II recalls without hospitalization reports and with theoretical hazards score as High (3).
Plain-English summary
Medline Industries, LP is recalling Centurion procedure packs containing Caina plastic syringes. These medical convenience kits are distributed worldwide and include multiple product types with various lot numbers.
The recall was initiated because the plastic syringes in these kits exhibit leaks, breakage, and other quality issues that may pose a risk to patient health. These defects were identified in connection with an FDA Safety Alert issued on March 19, 2024.
Healthcare facilities, hospitals, surgical centers, and medical practitioners who have received affected Centurion procedure packs should immediately stop using them. To determine if your inventory is affected, check the pack numbers and lot numbers of your kits against the list of recalled items provided by Medline Industries.
For additional information, contact Medline Industries directly or consult the FDA's official recall notice for detailed lot and pack number information.
The recalled product
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- breakage
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)
- DYNDH1446A
- Lot Number 2020102990
- MNS11965A
- Lot Number 2021061190
- Lot Number 2021072690
- Lot Number 2021083090
- Lot Number 2022041390
- Lot Number 2022091490
- Lot Number 2023041090
- MNS12670A
- Lot Number 2023060290
- DYNDH1512
- Lot Number 2021100490
- CIT7095
- CIT6535
- Lot Number 2024031880
- CIT7020
- Lot Number 2021120990
- CIT6720
- Lot Number 2022032290
Distribution
Distribution scope not specified by the agency.
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