Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling medical convenience kits due to quality issues in plastic syringes, including leaks and breakage that may affect patient safety. Affected products include tracheostomy kits and airway packs distributed worldwide.
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 Class II medical device recall involves risk-of-harm products—medical syringes and airway equipment. The source identifies quality defects (leaks and breakage) that may pose a risk to patient health, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits containing plastic syringes. The affected products include tracheostomy kits, medical emergency response tracheostomy kits, and flexible laryngeal mask airway packs in various sizes, distributed worldwide.
The recall is due to quality defects identified in the plastic syringes contained in these kits. Specifically, leaks, breakage, and other quality issues have been identified that may pose a risk to patient health. These defects were identified following an FDA Safety Alert issued on March 19, 2024.
Consumers with the affected products should verify their items against the pack and lot numbers provided in the FDA recall notice and contact their healthcare provider or Medline Industries for guidance on replacement or safe handling.
The recalled product
- Product
- Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DY
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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)
- CDS983142B
- Lot Number 19DBQ261
- Lot Number 19FBD886
- Lot Number 19KBJ083
- CDS984376B
- Lot Number 21HBJ875
- Lot Number 21JBJ731
- Lot Number 22DBM097
- Lot Number 22EBK349
- Lot Number 19EBI656
- Lot Number 22HBS594
- Lot Number 19SBG293
- Lot Number 19IBF800
- Lot Number 22LBA281
- Lot Number 23ABC499
- Lot Number 23ABE884
- Lot Number 19VBG331
- Lot Number 23BBS463
- Lot Number 20DBF949
- Lot Number 20EBU288
Distribution
Distribution scope not specified by the agency.
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