Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Mod

FDA device recall Z-1418-2023 · posted 2023-04-20 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

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 Cynthia.Ow@Olympus.com.

Root cause

Process change control

Status

Open, Classified

Product code

MND

Quantity affected

65.9 boxes (373 pieces)

Distribution

US Nationwide Distribution

Date initiated

2023-02-23

Date posted

2023-04-20

Location

Center Valley, PA

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