Arrow International, Llc: Percutaneous Sheath Introducer Kit
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Product
- PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
- Reason
- Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/db89671b-1861-4cf8-9a46-87ef4dba1908