Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect
Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls warrant a minimum severity score of 4. No illnesses, injuries, or deaths have been reported in the source material.
Plain-English summary
Medline Industries, LP is recalling Medline General Surgery Tray kits due to a manufacturing defect. The recalled products are the Arterial Line Tray (Item Number ART600) and A Line Tray (Item Number ART690). The catheter subassembly in these kits was manufactured with excess material on the catheter hub.
The recall affects 58 kits that were distributed nationwide in the United States. Affected items can be identified by their UDI codes and lot numbers: ART600 with UDI-DI 10653160312727 (lot 2024110190) and ART690 with UDI-DI 10653160318019 (lot 2024092490).
The recalled product
- Product
- Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 58
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 (6)
- 1) ART600 UDI-DI: 10653160312727 (each)
- 00653160312720 (case)
- Lot Number 2024110190
- 2) ART690 UDI-DI: 10653160318019 (each)
- 00653160318012 (case)
- Lot Number 2024092490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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