Recall Z-0507-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0507-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-10

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2023-10-10. It names one FDA 510(k) clearance: K083542. Product: Stay Safe Cap. Reason: Updating the labeling to include additional warnings and contraindications for potential side effects..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-10
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K083542 — FRESENIUS STERILE STAY SAFE CAPFresenius Medical Care North America·cleared 2008-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stay Safe Cap

Reason for recall

Updating the labeling to include additional warnings and contraindications for potential side effects.

Data sourced from openFDA. This site is unofficial and independent of the FDA.