BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70

FDA device recall Z-1188-2023 · posted 2023-02-28 · Open, Classified

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

Action taken

On February 13, 2023, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed of the potential packaging issues and the associated risks to health. Customers were instructed to stop use and return all unused and unexpired affected product for credit. If customers have no alternative product, they may choose to continue use of the product, but they must perform a visual inspection of the primary packaging, checking for visible stress marks or damage to the packaging. If there are visible stress marks in the packaging, the customer should not use the product. Please note that there is a possibility that packaging defects may not be detectable by the naked eye. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Root cause

Process control

Status

Open, Classified

Product code

DTZ

Quantity affected

10,587 units (US); 94,987 (worldwide)

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam,

Date initiated

2023-02-13

Date posted

2023-02-28

Location

Wayne, NJ

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