Home / Recalls / Aomori Olympus Co., Ltd. / Z-1039-2021

Z-1039-2021 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 6MMx 25G UPPER, model no. NM-610L-0625 - 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

05V, 06V, 07V, 08V, 09V, 0XV

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  • Z-2522-2023 Class II — Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attach (July 27, 2023)
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  • Z-1063-2021 Class II — PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with en (January 4, 2021)
  • Z-1005-2021 Class II — INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used wi (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-1056-2021 Class II — NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used wit (January 4, 2021)
  • Z-1036-2021 Class II — NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with e (January 4, 2021)