Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure
Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where freezing exposure may compromise sterility—a critical attribute for a dialysis connector. No illnesses or injuries reported. Per rubric: theoretical hazard with no reported harm scores at most 3.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 39 cases of the 050-95012 Sterile Stay Safe Cap due to exposure to freezing temperatures caused by a refrigerated truck malfunction during shipment. The Sterile Stay Safe Cap is a sterile medical device intended for use as a closure for peritoneal dialysis connectology systems.
Freezing exposure during transport may compromise the sterile integrity of the product, creating a potential risk to patients who would use these caps in their dialysis systems. Affected products bearing lot numbers B1ZH191 and B1ZI092 were distributed only to Texas.
The recalled product
- 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 s
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- temperature-exposure
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: B1ZH191
- B1ZI092
Distribution
Distributed in 1 state:
- TX
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