—#198981

Product

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

FDA product code: MND — Ligator, Esophageal
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K013066
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2023-02-23
Posted by FDA: 2023-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.