Medline recalls medical convenience kits with defective plastic syringes
Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.
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: FDA Class II device with confirmed quality defects in patient-care medical kits. No illnesses or injuries reported. Meets the 'High' severity criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple models of medical convenience kits distributed worldwide. These kits are used for various medical procedures including PICC line placement, central line insertion, vascular access procedures, and other interventions.
The plastic syringes in these kits have been identified as having quality defects including leaks, breakage, and other issues, as noted in an FDA Safety Alert issued March 19, 2024. These defects may compromise kit performance and pose a risk to patient health.
Healthcare facilities that have received the affected kits should immediately stop using them. Healthcare providers should verify their inventory against the lot numbers and pack numbers provided in the recall notice and contact Medline Industries for instructions regarding product return or replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- 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)
- 00-401649G
- Lot Number 19IMB453
- Lot Number 19KMA787
- Lot Number 19LMC950
- Lot Number 20EMA317
- Lot Number 20EMC074
- Lot Number 20HMA234
- Lot Number 20JME695
- Lot Number 20LME609
- Lot Number 21BME658
- Lot Number 21CMB025
- Lot Number 21CMD185
- Lot Number 21DMA102
- Lot Number 21JMA649
- Lot Number 21JMF121
- Lot Number 19BKC121
- Lot Number 19CKD014
- Lot Number 19EKA045
- Lot Number 19GKA016
- Lot Number 19HKB535
Distribution
Distribution scope not specified by the agency.
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