Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure
Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.
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 used for critical patient care. No illnesses or injuries reported, but freezing exposure poses a theoretical risk of compromising sterility and functionality, fitting the criterion for high-severity precautionary recalls.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Fresenius APD Luer-Lock Adapter (Catalog 050-95018), a device used to connect peritoneal dialysis bags to Fresenius Automated Peritoneal Dialysis (APD) cycler equipment such as the Liberty and Newton IQO cyclers.
The recall affects 5 cases (Lot 20LR08111) that were exposed to freezing temperatures due to refrigerated truck malfunctions during distribution. Freezing may have compromised the device's sterility or functionality, which could impact patient safety.
The affected product was distributed to Texas only. Patients and healthcare providers with devices matching Lot 20LR08111 should contact Fresenius Medical Care for information regarding replacement or inspection.
The recalled product
- Product
- The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, N
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 5
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 (1)
- Lot Number: 20LR08111 UDI: (01)00840861100811
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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