Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a 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 an FDA Class II recall of medical devices with identified quality defects (leaks, breakage) that pose a risk of harm to patients. No illnesses or injuries are reported in the source, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes. The affected products include CVC insertion packs, catheter insertion kits, chest insertion packs, ureteroscopy packs, tonsil packs, urology robotic packs, and port insertion packs. These kits were distributed worldwide.
The syringes in these kits are subject to an FDA Safety Alert issued on March 19, 2024, due to identified quality issues including leaks, breakage, and other defects. These quality problems may pose a risk to patient health during medical procedures requiring the use of these syringes.
Affected lot numbers span multiple years of manufacture. Healthcare providers who have received these kits should verify their lot numbers against the recall notice and follow their facility procedures for handling recalled medical devices.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leaks
- device-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)
- CVI4720A
- Lot Number 23DLA715
- Lot Number 23ELB184
- Lot Number 23GLA187
- Lot Number 23ILA599
- Lot Number 23ILA949
- Lot Number 23JLA318
- Lot Number 23JLB102
- CVI4720AH
- CVI4880
- Lot Number 22LBM567
- Lot Number 23HBU762
- DYNJ17634D
- Lot Number 23LBB611
- DYNJ45882A
- Lot Number 21HBE710
- Lot Number 21HBO631
- Lot Number 21JBD536
- Lot Number 21VBB891
- Lot Number 22ABC436
Distribution
Distribution scope not specified by the agency.
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