Medline Medical Convenience Kits Recalled for Defective Syringes
Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.
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 Class II medical device recall involving syringes with quality defects (leaks and breakage) that may pose risk to patient health during invasive medical procedures. No illnesses or injuries have been reported, characterizing this as a risk-of-harm scenario where injury has not yet occurred.
Plain-English summary
Medline Industries has recalled numerous sterile medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recalled products include over 80 different kit types used in various medical procedures, including myelogram packs, biopsy procedure packs, thoracentesis trays, and cardiac catheterization packs. These kits have been distributed worldwide.
The recalled syringes have quality defects including leaks and breakage. These issues may pose a risk to patient health during the procedures for which the kits are designed. Patients undergoing procedures should be aware that their healthcare provider may have received these affected kits.
Healthcare facilities and providers should stop using the affected kits immediately and review the FDA's complete list of recalled product names and lot numbers (FDA recall number Z-3019-2024) to identify affected inventory. Contact Medline Industries for instructions on returning or properly disposing of the recalled products.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Numbe
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-defect
- 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)
- 00-399025L
- Lot Number 23LMB058
- Lot Number 23LMG684
- Lot Number 23LMH827
- Lot Number 24AMC410
- Lot Number 19ELA658
- Lot Number 19KLA410
- Lot Number 20BLA276
- Lot Number 20CLA517
- Lot Number 20GLA372
- Lot Number 20JLA514
- Lot Number 21ELA301
- Lot Number 21HLA415
- Lot Number 21JLA793
- Lot Number 22CLA145
- Lot Number 22ELA199
- Lot Number 22ELA628
- Lot Number 22JLA233
- Lot Number 23ALA823
- Lot Number 23ELA753
Distribution
Distribution scope not specified by the agency.
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