Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect
Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification combined with manufacturing defect in a medical device component used for arterial access. No deaths or serious injuries reported in the source, preventing a Critical rating.
Plain-English summary
Medline Industries is recalling 942 units of arterial line insertion and related surgical kits. The recall affects multiple product models distributed nationwide, including the Arterial Line Insertion Kit (Item ART1185B), Arterial Line Bundles (Items ART255, ART355), Arterial Line Trays (Items ART350, ART545A, ART840), and other related products.
The catheter subassembly in the Integrated Arterial Catheter component of these kits was manufactured with excess material on the catheter hub. This manufacturing defect led to a FDA Class I recall.
Affected products are identified by specific lot numbers and UDI codes detailed in the official FDA recall notice. The kits were manufactured in 2024 and distributed throughout the United States.
The recalled product
- Product
- Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- catheter-defect
- manufacturing-defect
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)
- 1) ART1185B UDI-DI: 10653160379225(each)
- 00653160379228(case)
- Lot Number: 2024102590
- 2) ART255 UDI-DI: 10653160367598(each)
- 00653160367591(case)
- Lot Number: 2024082690
- 3) ART255 UDI-DI: 10653160367598(each)
- Lot Number: 2024101590
- 4) ART350 UDI-DI: 10653160362050(each)
- 00653160362053(case)
- Lot Number: 2024093090
- 5) ART355 UDI-DI: 10653160361817(each)
- 00653160361810(case)
- Lot Number: 2024081290
- 6) ART355 UDI-DI: 10653160361817(each)
- Lot Number: 2024112590
- 7) ART475 UDI-DI: 10653160367659(each)
- 00653160367652(case)
- Lot Number: 2024100790
- 8) ART475 UDI-DI: 10653160367659(each)
Distribution
Distributed nationwide across the United States.
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