Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential 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: This is an FDA Class II recall involving medical devices with identified quality defects (leaks and breakage) that pose potential harm to patients. No illnesses or injuries have been reported, making this a risk-of-harm product where actual injury has not yet been documented, fitting the High severity category.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The affected kits are identified by multiple pack numbers and lot numbers.
The recalled syringes have been identified with quality issues including leaks and breakage. These defects may pose a risk to patient health and safety during medical procedures.
The recall affects convenience kits distributed worldwide. Healthcare facilities and individuals using these products should discontinue use and contact Medline Industries for replacement instructions or further guidance.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- breakage
- quality-defect
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 (9)
- DYNJ0621408V
- Lot Number 23ILB053
- DYNJ0621408VH
- DYNJ0864492A
- Lot Number 21KMH585
- DYNJ0864492AH
- SAMP0545
- Lot Number 22GME387
- Lot Number 22GME980
Distribution
Distribution scope not specified by the agency.
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