Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
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: The recall is classified as FDA Class II, and the source text states that the defects 'may pose a risk to patient health' without reporting specific injuries or illnesses, which aligns with the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific medical convenience kits, including laceration trays, closure packs, and suture trays, that contain plastic syringes. The recall is related to an FDA Safety Alert issued on March 19, 2024, which identified leaks, breakage, and other quality issues in the syringes.
The affected products are distributed worldwide and include various pack numbers and lot numbers, such as DYKMBNDL200A, DYNDL1495A, and SUT20285A. The identified quality issues may pose a risk to patient health.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY…
- 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)
- DYKMBNDL200A
- Lot Number 22KBD675
- Lot Number 23KBA331
- DYKMBNDL200AH
- DYNDA2415B
- Lot Number 23JLA114
- Lot Number 24BLB045
- DYNDL1495A
- Lot Number 22LBJ768
- Lot Number 23ABG899
- Lot Number 23CBF146
- Lot Number 23DBO301
- Lot Number 23EBC524
- Lot Number 23EBR564
- Lot Number 23GBC601
- Lot Number 23HBF407
- Lot Number 23IBR368
- Lot Number 23KBF026
- DYNDL1495AH
- DYNDL1807B
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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