Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2335-2017
Product Description
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 27,485 units distributed in U.S., 4,371 units distributed internationally
- Distribution
- Worldwide Distribution - US (nationwide) and Canada
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation. Recalled by Arrow International Inc. Units affected: 27,485 units distributed in U.S., 4,371 units distributed internationally.
Why was this product recalled? ▼
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2335-2017.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11