Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affecte

FDA device recall Z-0910-2023 · posted 2023-01-06 · Open, Classified

Recall details

Recalling firm

Bayer Medical Care, Inc.

Reason for recall

Black specks may be present on the packaged needles

Action taken

Bayer US issued Urgent Medical Device Recall (RECALL ID: SA-22-RAD-05 ) Letter on 11/30/22 via email. Letter states reason for recall, health risk and action to take: 1. Review your current inventory for affected Lot 60272154 and quarantine, as appropriate. 2. Complete the included response form and submit through email to ricustomercare@bayer.com or contact our Bayer Customer Service team at 1-800-633-7231, Press 0, then option 3. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all impacted product. 3. You will receive a Return Goods Authorization (RGA) number to return any affected kits remaining in your inventory for a credit. 4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return affected product as soon as possible 5. Upon Bayer receipt of returned product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FRN

Quantity affected

2840 units

Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.

Date initiated

2022-11-30

Date posted

2023-01-06

Location

Indianola, PA

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