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Single Use Rotatable Clip Fixing Device recallZ-1418-2023 · Olympus Corporation of the Americas · initiated Feb 23, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There have been complaints that the clip did not come out of the tube sheath during the procedure.

FDA root cause category: Process change control

What the company is doing

The firm, Olympus, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 2/23/2023 to its customers. The letter described the product, the issue and actions to be taken. The customers were instructed to do the following: 1) immediately assess, cease use of and quarantine any affected (lot numbers) products you have identified. 2.) Call your Olympus customer service representative at 1-800-848-9024, option 2 to receive a RMA to return any affected product at not charge. 3.)Access the Olympus recall portal to indicate that you have received this notification at https://olympusamerica.com/recall. Enter the recall number "0421" and provide your contact information as indicated in the portal. 4.) If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Please report to Olympus any adverse events and irregularity associated with the use of the devices by contacting our Technical Assistance Center at 1 800 848 9024, option 1. Please reach out to your local sales representative for assistance regarding current product offerings. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or [email protected].

Recall details

Recall number
Z-1418-2023
Status
Open, Classified
Initiated by the company
Feb 23, 2023
Posted by the FDA
Apr 20, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
65.9 boxes (373 pieces)
Product code
MND
FDA submissions
K013066
Distribution
US Nationwide Distribution

Product description

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

Code information (models, lots, serial numbers)

1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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