Fresenius Medical Care Holdings, Inc. 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
Lot Number: B1ZH191, B1ZI092
Products Sold
Lot Number: B1ZH191, B1ZI092
Fresenius Medical Care Holdings, Inc. is recalling 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay due to Exposed to freezing temperatures due to refrigerated truck malfunctions. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Exposed to freezing temperatures due to refrigerated truck malfunctions
Recommended Action
Per FDA guidance
Fresenius issued telephone script communication on April 28.2021 stating reason for recall, heath risk and action to take: Tell them you already contacted their Home Therapy Nurse to alert them that you would be calling them. o The purpose of my call today is that you received a delivery from us on (either Feb 22nd or Feb 23rd). o The truck you received a delivery from had a temperature malfunction due to the bad storms Texas experienced back in February. This caused the product you were delivered to be exposed to freezing or near freezing temperatures for about 3 hours. o o I see you received on . o (if received any PD SOLUTION/SALINE/or CONCENTRATES): Explain that the solutions inside their product are not affected and that we have freeze/thaw studies that prove this. Explain that due to the freezing temperatures, the packaging may become compromised, and they may have seen leaks. For the other products such as Hand Sanitizer and other ancillary products, again, the product could be compromised according to their packaging requirements listed on their packaging. o We are giving you the opportunity to return these products if you choose to do so at this time. o If returning product(s): o Fill out RGA spreadsheet with customer information including how much product they are returning (include lot# and amount returning). Driver will pick up returned products on their next scheduled visit. Fresenius Corrections and Removals Rep: Email Post Market Surveillance to open a complaint against product. o If not returning product(s): o Thank them for their time and reiterate to always inspect their packaging for leaks as this is what they are trained to do anyways from their Home Therapies Nurse. If you have any questions call 781-699-2243 or email: beth.st.germain@fmc-na.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX
Page updated: Jan 10, 2026