Medline Medical Convenience Kits Recalled for Plastic Syringe Quality Issues
Medline is recalling multiple convenience kits containing defective plastic syringes that may leak or break, posing potential patient health risks. The defective syringes were identified through 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 an FDA Class II medical device recall affecting surgical and clinical convenience kits with plastic syringe quality defects (leaks and breakage). While the defects represent a risk-of-harm to patients, no illnesses or injuries have been reported. Per the rubric, this qualifies as High (3) severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling multiple medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The syringes are subject to leaks, breakage, and other quality issues that may pose a risk to patient health.
The recall affects 19 different convenience kit models, including ECMO insertion bundles, PORT access trays, knee arthroscopy packs, catheterization kits (PICC kits, IR central kits), umbilical vessel trays, and other surgical procedure kits. The affected kits have been distributed worldwide.
Defective syringes with leaks or breakage could compromise the safety and effectiveness of medical procedures, particularly in invasive applications such as ECMO insertion, catheterization, and surgical interventions. No illnesses or injuries have been reported to date.
Healthcare providers and facilities that have received affected lots should discontinue use immediately and contact Medline Industries for further instructions on replacement or return procedures.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PA
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leakage
- syringe-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)
- CVI4915
- Lot Number 2022103180
- DYNDC1318D
- Lot Number 2019012590
- DYNJ0101308C
- Lot Number 19BKC672
- DYNJ04047C
- Lot Number 21FBN548
- Lot Number 21GBL027
- Lot Number 21IBX365
- Lot Number 22ABM052
- Lot Number 19ABD460
- Lot Number 22CBP491
- Lot Number 22OBI898
- Lot Number 19FBD994
- Lot Number 22IBH860
- Lot Number 22IBJ054
- Lot Number 22LBR925
- Lot Number 19VBB656
- Lot Number 23ABS681
Distribution
Distribution scope not specified by the agency.
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