FDA Recall Open, Classified

Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

Recall: Z-2523-2023 · Initiated July 27, 2023

Recall

Recall Number: Z-2523-2023
Event Number: 92784
Firm: Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan
FEI Number: 3003995201
Product Code: FDS
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: July 27, 2023
Posted: September 7, 2023

Description

Reason

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

Action

Olympus issued Urgent Medical Device Recall Letter dated July 27, 2023 to ENDOSCOPY DEPARTMENT, RISK MANAGEMENT. Letter states reason for recall, health risk and action to take: Immediately assess any product you have to identify the product number with affected lot listed in this communication, cease use and quarantine any affected products. The image below depicts the area where the lot number is identified. The lot# is on the Carton box and Pack. Please refer to Attachment 2 for the identification of the subject products. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility for your affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0429 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including patient physical condition suspected to be affected by DEHP, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at [email protected].

Distribution

US Nationwide distribution.

Quantity

1,252 units