Medline Convenience Kits With Syringes Recalled for Quality Defects
Medline is recalling medical convenience kits containing syringes due to quality issues including leaks and breakage. These defects may pose a risk to patient health and were identified in relation to an FDA Safety Alert issued March 19, 2024.
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 a FDA Class II medical device recall involving syringes with confirmed quality defects (leaks and breakage) that pose a potential risk to patient health. However, no reported illnesses, injuries, or hospitalizations have been documented, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries is recalling Convenience kits containing Shenli syringes across three pack numbers: DYNJ34129C, DYNJ54607A, and DYNJ61839B. Multiple lot numbers are affected as identified in the recall notice.
The recall was initiated because plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks, breakage, and other defects have been identified that may pose a risk to patient health.
These products have been distributed worldwide. Consumers and healthcare providers who have received these kits should check their lot numbers against the list provided in the FDA recall notice and contact Medline Industries for guidance.
Healthcare facilities and individuals using these syringes should stop use and contact the manufacturer for instructions regarding return or replacement of affected products.
The recalled product
- Product
- Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- 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 (20)
- DYNJ34129C
- Lot Number 21GBT130
- Lot Number 21LBL623
- Lot Number 22ABM033
- Lot Number 22ABX499
- Lot Number 19BBD954
- Lot Number 19DBZ455
- Lot Number 19EBU077
- Lot Number 19GBU537
- Lot Number 22IBG550
- Lot Number 19JBN034
- Lot Number 20BBF056
- Lot Number 23FBG792
- Lot Number 23GBE376
- Lot Number 20FBS002
- Lot Number 23JBR570
- Lot Number 23JBY629
- Lot Number 23KBU960
- Lot Number 23KBW607
- Lot Number 20KBW597
Distribution
Distribution scope not specified by the agency.
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