Medline recalls three medical procedure kits with defective plastic syringes
Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been 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 is an FDA Class II recall of medical device kits used in surgical procedures. The identified defects (leaks and breakage in syringes) could create risks during patient care, but no illnesses or injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling three medical device procedure kits: Carotid Endarterectomy Pack (DYNJ85516), PICC Insertion Tray Without Catheter (PICCNC0004), and Vascath Insertion Pack (CVI4825). These kits contain plastic syringes that have been affected by an FDA Safety Alert issued on March 19, 2024, and have been identified with leaks, breakage, and other quality issues.
The identified quality issues in the plastic syringes may pose a risk to patient health. The affected kits have been distributed worldwide. Multiple lot numbers across the three product types are included in this recall.
The recalled product
- Product
- Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
- 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 (11)
- DYNJ85516
- Lot Number 23JBI659
- Lot Number 23LBE170
- Lot Number 23LBR472
- PICCNC0004
- Lot Number 23JMG079
- CVI4825
- Lot Number 22FLA595
- Lot Number 22JLA721
- Lot Number 22JLB203
- Lot Number 22KLA852
Distribution
Distribution scope not specified by the agency.
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