—#168903

Product

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K831931
Affected lot / code info: ME221275

Why it was recalled

This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.

Root cause (FDA determination)

Vendor change control

Action the firm took

The firm notified affected customers on October 29, 2018 via an Urgent Medical Device Recall letter. The letter alerted customers to the issue of the product's sterile barrier pouch not being properly sealed at the bottom. Customers were asked to do the following: 1. Examine your inventory to determine if you have the affected product listed in this Notification. If so, remove affected products, quarantine them, and place in a secure location. 2. If you have affected product, contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm (EST), for a Return Authorization (RA) to return the product for replacement or credit. 3. Complete and sign the enclosed Medical Device - Recall Response Form on Page 4 of this letter to acknowledge receipt of this notification. If you have affected product to return, enter the quantity and your RA number in the space provided. 4. Return the completed Medical Device - Recall Response Form to: EMAIL catheter2018.us@getinge.com or FAX 1-973-807-1654. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.

Timeline

Recall initiated: 2018-10-12
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.