Medline convenience kits recalled for syringe leaks and breakage defects
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
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 actual identified defects (leaks and breakage) in medical devices used in surgical procedures. While the defects pose a risk to patient health, no injuries or hospitalizations have been reported, placing it in the High category per the severity rubric.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits that contain plastic syringes. The recalled kits include various urology minor trays, circumcision trays, and related surgical packs with specific model and lot numbers listed in the FDA recall notice.
The plastic syringes in these kits are affected by a defect described in an FDA Safety Alert issued on March 19, 2024. The syringes have exhibited leaks, breakage, and other quality issues that may pose a risk to patient health.
The recalled kits have been distributed worldwide. Persons who have these kits should stop using them and contact Medline Industries for information about the recall and how to proceed with return or replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Nu
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Hazard
- leak
- breakage
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)
- CDS980371J
- Lot Number 19BBJ528
- Lot Number 19BBS356
- Lot Number 19DBR965
- Lot Number 19EBX731
- Lot Number 19GBJ926
- Lot Number 19HBY831
- Lot Number 19IBL323
- CDS980371K
- Lot Number 21GBD850
- Lot Number 21HBI925
- Lot Number 21JBJ715
- Lot Number 19LBF128
- Lot Number 20BBU821
- Lot Number 20FBB764
- Lot Number 20GBR055
- Lot Number 20JBT054
- Lot Number 20LBC968
- Lot Number 21BBE923
- Lot Number 21BBG105
Distribution
Distribution scope not specified by the agency.
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