Home / Recalls / Aomori Olympus Co., Ltd. / Z-1063-2021

Z-1063-2021 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

PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

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

97K

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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-0994-2021 Class II — INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Us (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-1062-2021 Class II — NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-40 (January 4, 2021)
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  • Z-0967-2021 Class II — B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Use (January 4, 2021)
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