Home / Recalls / Aomori Olympus Co., Ltd. / Z-1050-2021

Z-1050-2021 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

K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

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, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

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-1013-2021 Class II — INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Us (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)
  • 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-0981-2021 Class II — KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endo (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-0976-2021 Class II — KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endo (January 4, 2021)