Home / Recalls / Arrow International Inc / Z-1297-2018

Z-1297-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
October 24, 2017
Termination Date
April 17, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30,577 eaches

Product Description

Large Volume Abdominal Paracentesis Kit

Reason for Recall

Product packaging may not be completely sealed.

Distribution Pattern

Nationally

Code Information

AK 00376

Other recalls by Arrow International Inc

  • Z-3299-2024 Class II — Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with (July 26, 2024)
  • Z-1879-2024 Class I — Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF (April 29, 2024)
  • Z-1878-2024 Class I — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) (April 29, 2024)
  • Z-1880-2024 Class I — Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) RE (April 29, 2024)
  • Z-1267-2024 Class I — ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbe (February 12, 2024)
  • Z-2591-2023 Class II — Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Sty (August 10, 2023)
  • Z-0004-2024 Class I — Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre- (August 10, 2023)
  • Z-2590-2023 Class II — Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter (August 10, 2023)
  • Z-0003-2024 Class I — Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1 (August 10, 2023)
  • Z-0001-2024 Class I — Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-l (August 10, 2023)