Recalls / —

—#204279

Product

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

FDA product code

GBZ — Catheter, Cholangiography

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K831931

Affected lot / code info

UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.

Why it was recalled

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.

Recalling firm

Firm

Atrium Medical Corporation

Address

40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern

US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX

Timeline

Recall initiated

2023-09-29

Posted by FDA

2023-12-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.