Medline Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states that the quality issues 'may pose a risk to patient health,' which aligns with the rubric criteria for a Severe rating involving significant injury risk or Class II classification with potential harm.
Plain-English summary
Medline Industries, LP is recalling specific C Scope Disposable Kits (Pack Codes 613034700, 613034701, and 613034702) distributed worldwide. The recall is initiated because these medical convenience kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.
The FDA identified leaks, breakage, and other quality issues with the syringes that may pose a risk to patient health. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and consumers should stop using the affected kits immediately. The specific lot numbers involved are listed in the structured product information. Users should contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
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)
- 613034700
- Lot Number 20ADD340
- Lot Number 20BDC393
- Lot Number 20BDC472
- Lot Number 20BDC473
- Lot Number 20FDA390
- Lot Number 20FDA896
- Lot Number 20FDA897
- Lot Number 20FDA898
- Lot Number 20FDA896A
- Lot Number 20JDB120
- Lot Number 21CDA660
- Lot Number 21DDB193
- Lot Number 21IDA396
- Lot Number 21LDB900
- Lot Number 22ADB549
- 613034701
- Lot Number 21CDA617
- Lot Number 21DDB192
- Lot Number 21IDB791
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 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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