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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 27 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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