Medline Convenience Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects 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: The recalled medical device kits contain plastic syringes with identified quality defects that may pose a risk to patient health. This FDA Class II recall involves risk-of-harm products with no reported illnesses or injuries to date.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes affected by identified quality issues. The recalled kits are used for various clinical procedures including dialysis catheter insertion, ultrasound-guided biopsies, lumbar puncture, and arthrography.
These kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. Identified quality issues include leaks, breakage, and other defects that may pose a risk to patient health during clinical use.
The affected kits have been distributed worldwide. Multiple lot numbers of the recalled products are involved.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- 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 (15)
- CVI4815
- Lot Number 2022031150
- Lot Number 2022042250
- Lot Number 2022121390
- CVI5045
- Lot Number 2023101290
- DYNDA2906
- DYNDH1319
- DYNDH1693A
- DYNDL1461
- DYNJTS4306
- SPEC0143A
- UVT1205
- Lot Number 2022072650
- Lot Number 2022081650
Distribution
Distribution scope not specified by the agency.
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