—#185178

Product

B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K091495
Affected lot / code info: 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 4, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the identified list of Endo-therapy devices may have a defective seal which may compromise the sterility of the product. Customers were asked to take the following actions: 1. Immediately assess any product you have in stock to identify endotherapy products with affected lot numbers listed in the recall letter. Cease use of product and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit or replacement to your facility for any returned product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0391 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 corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Recalling firm

Firm: Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-01-04
Terminated: 2024-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185178. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.