Medical Convenience Kits with Defective Plastic Syringes Recalled Worldwide
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.
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 recall involving plastic syringes with documented quality defects (leaks, breakage) used in invasive procedures. No illnesses or injuries are reported in the source text, making this a risk-of-harm product defect without confirmed patient harm.
Plain-English summary
Medline Industries is recalling medical convenience kits distributed worldwide due to plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recall involves 23 different kit types used for invasive medical procedures, including bone marrow biopsies, lumbar punctures, arthrograms, and ultrasound-guided procedures.
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues. These defects may compromise the integrity of the syringes during medical procedures, potentially posing a risk to patient health.
The affected kits were distributed worldwide to healthcare facilities and practitioners. Multiple lot numbers spanning from 2019 to 2024 are included in this recall.
Patients and healthcare providers should contact Medline Industries or the FDA with questions about whether their kits are affected and appropriate next steps for replacement or disposal.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPS
- 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)
- DM645
- Lot Number 2019120980
- DYNDC1960A
- Lot Number 2022040790
- DYNDH1319
- Lot Number 2020122250
- DYNDH1324A
- DYNDH1514
- Lot Number 2020040250
- Lot Number 2020050750
- DYNDH1570
- Lot Number 2022011450
- DYNDH1574
- DYNDH1596
- Lot Number 2022092090
- DYNDH1638
- Lot Number 2021062150
- Lot Number 2021092350
- Lot Number 2022060750
- DYNDH1699
Distribution
Distribution scope not specified by the agency.
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