Medline Centurion Procedure Packs Recalled Due to Syringe Quality Issues
Medline Industries is recalling Centurion procedure packs containing defective Caina syringes due to leaks and breakage risks.
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: The recall involves a medical device with identified quality defects (leaks/breakage) that pose a risk to patient health, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific Centurion procedure packs that contain Caina syringes. The affected products are labeled as CIRCUMCISION TRAY (Pack Number CIT6860A) and RETINAL INJECTION KIT (Pack Number MNS12465). The recall covers worldwide distribution.
The recall is being conducted because the plastic syringes included in these kits are affected by an FDA Safety Alert issued on March 19, 2024. The alert identified leaks, breakage, and other quality issues that may pose a risk to patient health.
Healthcare facilities and consumers should stop using the affected packs immediately. The specific lot numbers involved are 2022011080 for the Circumcision Tray and 2021092780 for the Retinal Injection Kit.
The recalled product
- Product
- Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
- 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 (4)
- CIT6860A
- Lot Number 2022011080
- MNS12465
- Lot Number 2021092780
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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