Centurion Procedure Kits with Defective Syringes Recalled Worldwide
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential 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: This is a Class II medical device recall involving potential quality defects in syringes used in medical procedures. While no illnesses or injuries have been reported, defective syringes that may leak or break represent a risk-of-harm product where equipment failure could affect patient safety.
Plain-English summary
Medline Industries is recalling Centurion procedure kits labeled as NEURO ANGIO PACK (Pack Number DYNDA1431A, Lot Number 2019072590) due to quality defects in the plastic syringes contained within these medical convenience kits.
The syringes were identified as affected by an FDA Safety Alert issued on March 19, 2024. Reported issues include leaks, breakage, and other quality problems that may pose a risk to patient health.
The kits have been distributed worldwide. Healthcare providers and facilities using these procedure kits should contact Medline Industries for further guidance regarding this recall.
The recalled product
- Product
- Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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 (1)
- Lot Number 2019072590
Distribution
Distribution scope not specified by the agency.
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