Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport
A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for temperature-related exposure during distribution of a critical-care dialysis device. No illnesses or injuries reported. Score reflects risk-of-harm category due to the patient-critical nature of peritoneal dialysis, but is capped at 3 by the absence of reported injury.
Plain-English summary
The Drain Bag Set is a passive, closed drainage system used during automated peritoneal dialysis (APD) treatment to collect patient effluent in bags as an alternative to direct drain connection. The device consists of three interconnected 7-liter drain bags with sampling ports and tubing with snap-disconnect couplings.
Units in Lot 20NR08163 were exposed to freezing temperatures due to malfunctions in the refrigerated transport vehicle during distribution. Approximately 10 cases were distributed to Texas.
Fresenius Medical Care is recalling the affected Drain Bag Sets due to exposure to freezing temperatures during transport. Patients or healthcare providers using units from this lot should contact Fresenius Medical Care for guidance on continued use or replacement.
The recalled product
- Product
- The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects…
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 10
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: 20NR08163 UDI: (01)00840861102037
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.
See all 9 products in this recall →Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
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