Medline Centurion Procedure Packs with Syringes Recalled for Defects
Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 issues including leaks and breakage. The source states the hazard "may pose a risk to patient health," but no reported illnesses or injuries are documented. Per the rubric, a risk-of-harm product where injury has not yet been reported receives a score of 3.
Plain-English summary
Medline Industries, LP is recalling Centurion procedure packs (Pack Number MNS8250, Lot Number 2022111790) containing Caina syringes labeled as SHAVE KIT. The recalled products have been distributed worldwide.
The syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. The FDA has identified leaks, breakage, and other quality issues in the affected syringes that may pose a risk to patient health.
Healthcare facilities and individuals who have received these procedure packs should discontinue use immediately. Contact Medline Industries for further information or replacement options.
The recalled product
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (2)
- MNS8250
- Lot Number 2022111790
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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