Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical 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 a Class II recall of risk-of-harm medical devices (syringes) with identified defects that may pose patient risks. No illnesses or injuries have been reported, and the hazard is identified but not yet realized, meeting the criteria for High severity.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits containing plastic syringes. The recall was prompted by an FDA Safety Alert issued on March 19, 2024. Over 80 different product types are affected, with worldwide distribution.
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health. Affected lot numbers and specific product pack numbers are listed in the FDA recall notice.
Healthcare facilities and individuals who have these kits should stop using them and verify their inventory against the affected product names and lot numbers provided by the FDA. Contact Medline Industries for replacement units or additional information.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- 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)
- 00-RDF036O
- Lot Number 24BMG670
- 00-RDF036OH
- Lot Number 22FMH197
- Lot Number 22IMC476
- Lot Number 22JMD690
- Lot Number 22KMB816
- Lot Number 22LMB962
- Lot Number 23BMA905
- Lot Number 23BMH681
- Lot Number 23CMG412
- Lot Number 23DMI750
- Lot Number 23IMD552
- Lot Number 23KMD849
- 0M-CP31433J
- Lot Number 24DBD373
- ART1210
- Lot Number 2023121890
- BM17BAD
- Lot Number 22FBA406
Distribution
Distribution scope not specified by the agency.
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