Medline Recalls Dialysis Convenience Kits Due to Syringe Quality Issues
Medline is recalling dialysis convenience kits containing plastic syringes affected by an FDA Safety Alert. Leaks and breakage may pose a 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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling specific dialysis convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected products include various dialysis catheter access kits, dialysis packs, and AV shunt kits. The recall covers worldwide distribution.
The recall is being conducted because leaks, breakage, and other quality issues have been identified in the plastic syringes. These defects may pose a risk to patient health. The source text does not report any specific illnesses or injuries associated with these units.
Healthcare providers and patients should stop using the affected kits and contact Medline Industries for further instructions. The specific pack numbers and lot numbers involved are listed in the official recall documentation.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS P
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Dialysis Kits
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 (18)
- DYNDA2516B
- Lot Number 23IBE112
- Lot Number 23JBH284
- Lot Number 23KBE900
- Lot Number 23LBO850
- DYNDA2516BH
- DYNJ36932A
- Lot Number 23FBK320
- Lot Number 23GBU834
- Lot Number 23HBG572
- Lot Number 23LBL499
- DYNJ58502C
- Lot Number 21IMD970
- Lot Number 21KMA999
- DYNJ910121
- Lot Number 24CDB254
- PICCNC0028
- Lot Number 23KBL354
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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