Arrow PICC Kit Recall Issued for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 190 units of Arrow PICC Kits due to incorrect expiration dates printed on the product.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc. is recalling 190 units of Arrow PICC Kits pre-loaded with Arrow VPS Precision Stylet, Product Code ASK 45552 CRM. The recall was initiated because the product was labeled with an incorrect expiration date.
The affected products are identified by batch codes 13F17J0016 and 13F17M0213. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide and to foreign locations.
Healthcare facilities and distributors should stop using the affected products and contact Arrow International Inc. for instructions on how to return them. No specific instructions for individual consumers are provided in the source text, as these are medical devices typically used in clinical settings.
The recalled product
- Product
- Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — PICC Kit
- Hazard
- Affected units
- 190
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 (2)
- Batch Code:13F17J0016
- 13F17M0213
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 36 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 36 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 Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateArrow PICC Recall for Incorrect Length Labeling
FDA (Devices) · 2019-05-22
- SevereArrow PICC Catheters Recalled for Incorrect Product Label Information
FDA (Devices) · 2023-10-11
- ModerateArrow International Recalls PICC Sets with Incorrect Expiration Dates
FDA (Devices) · 2020-02-26
- ModerateArrow PSI Kit Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2020-02-26
- ModerateArrow International Recalls PICC Catheter Kits Due to Incorrect Components
FDA (Devices) · 2018-02-21
- LowArrow ErgoPack PICC catheter kits recalled for incorrect product labeling
FDA (Devices) · 2023-09-27