Home / Recalls / Aomori Olympus Co., Ltd. / Z-1034-2021

Z-1034-2021 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 5MMx 21G UPPER, model no. NM-610L-0521 - 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, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 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-0976-2021 Class II — KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endo (January 4, 2021)
  • Z-0966-2021 Class II — B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Use (January 4, 2021)
  • Z-1024-2021 Class II — INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Use (January 4, 2021)
  • Z-0982-2021 Class II — KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endo (January 4, 2021)
  • Z-0990-2021 Class II — SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used wit (January 4, 2021)
  • Z-0981-2021 Class II — KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endo (January 4, 2021)
  • Z-0968-2021 Class II — B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Use (January 4, 2021)
  • Z-0969-2021 Class II — PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscop (January 4, 2021)