Home / Recalls / Aomori Olympus Co., Ltd. / Z-1043-2021

Z-1043-2021 Class II Terminated

Recalled by Aomori Olympus Co., Ltd. — Kuroishi, N/A

Recall Details

Product Type
Devices
Report Date
February 17, 2021
Initiation Date
January 4, 2021
Termination Date
March 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,400,000 (globally); 260,395 (US)

Product Description

NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Reason for Recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Distribution Pattern

US Nationwide distribution.

Code Information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Other recalls by Aomori Olympus Co., Ltd.

  • Z-2522-2023 Class II — Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attach (July 27, 2023)
  • Z-2523-2023 Class II — Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH (July 27, 2023)
  • Z-0994-2021 Class II — INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Us (January 4, 2021)
  • Z-1063-2021 Class II — PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with en (January 4, 2021)
  • Z-1069-2021 Class II — NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usag (January 4, 2021)
  • Z-0961-2021 Class II — B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to (January 4, 2021)
  • Z-0992-2021 Class II — SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: (January 4, 2021)
  • Z-1062-2021 Class II — NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-40 (January 4, 2021)
  • Z-0991-2021 Class II — SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: (January 4, 2021)
  • Z-1054-2021 Class II — NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used wit (January 4, 2021)