FDA Medical devices recall ·
ARROW RADIAL ARTERY CATHETERIZATION KIT recall
- Recall number
- Z-1911-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Arrow International, LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 675
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
Why was it recalled?
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product code:ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25J0352 Product code: ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 Batch Number: 33F25J0869 Product code: ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 Batch Number: 33F25J0870 Product code: ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 Batch Number: 33F25J0880
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
States: Arizona California Georgia Massachusetts Maine Michigan Oregon Pennsylvania Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1911-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.