Centurion medical syringes recalled for leaks and breakage
Medline recalls Centurion procedure packs containing Caina syringes due to leaks, breakage, and quality issues that may pose risks to patient health in surgical procedures.
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 medical device recall. While no illnesses or injuries are reported in the source text, the identified leaks and breakage in syringes used in sensitive surgical procedures (circumcision, retinal injection) pose a documented risk to patient health.
Plain-English summary
Medline Industries is recalling Centurion procedure packs containing Caina syringes. The affected products include the NICU Circumcision Tray without Clamp (Pack Number CIT6920, Lot Number 2021092290) and the Retinal Injection Kit (Pack Number MNS12465, Lot Number 2022040190).
The recall relates to a March 19, 2024 FDA Safety Alert concerning leaks, breakage, and other quality issues identified in the plastic syringes. These defects may pose a risk to patient health, particularly in surgical and injection procedures.
The affected procedure packs have been distributed worldwide. Healthcare facilities using these product numbers and lot numbers should identify and isolate affected units. Customers who have received these products should stop use and contact Medline Industries for instructions on disposition.
The recalled product
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- 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 (4)
- CIT6920
- Lot Number 2021092290
- MNS12465
- Lot Number 2022040190
Distribution
Distribution scope not specified by the agency.
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