Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes
Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes because unsealed packaging may compromise product sterility.
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: The recall involves a medical device where sterility may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes (Product Code: LR-05501). The recall involves 416,055 units distributed in the United States and 35 other countries, including Australia, Canada, and the United Kingdom.
The recall was initiated because product sterility may be compromised due to unsealed packaging. The affected lot numbers are 13F17C0328, 13F17F0296, 13F17G0202, 13F17H0104, and 13F17J0207.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected syringes. Consumers should contact their healthcare provider for guidance if they have used these products.
The recalled product
- Product
- 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Syringes
- Affected units
- 416,055
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 (1)
- Lot Numbers: 13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International Inc 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.
See all 76 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereArrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes
FDA (Devices) · 2020-02-19
- ModerateArrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components
FDA (Devices) · 2014-10-29
- HighArrow Select Kits Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2014-10-22
- Severe10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage
FDA (Devices) · 2023-10-18
- SevereFDA Recalls Fresenius 10mL Luer Lock Syringes Due to Leakage and Foreign Material
FDA (Devices) · 2023-10-18
- HighArrow International Recalls Multi-Lumen Hemodialysis Catheterization Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18