MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206
Summary
The FDA issued a Class II for MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF by ARROW INTERNATIONAL, LLC. Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.
Details
Source
Device Recall
External ID
Z-1916-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.
Lot/Code Info: Product Code: ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
Quantity Affected: 90
Reason for Recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-11
Company
Morrisville, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARROW INTERNATIONAL, LLC have FDA actions?
ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1916-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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