WalkMed Infusion Pump Reservoir Bags Recalled for Fluid Leaks
WalkMed, LLC is recalling 25,920 infusion pump reservoir bags due to reported fluid leaks at the luer connection.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (fluid leakage) from a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
WalkMed, LLC is recalling 25,920 units of Reservoir Bags for the WalkMed Infusion Pump. The affected products include Part Number 204820 (Catalog Number IPR-86/10, 65 mL) and Part Number 204821 (Catalog Number IPR-150/10, 150 mL). These bags are designed for use with the WalkMed 350VL Ambulatory pump to administer intravenous, subcutaneous, arterial, enteral, and epidural infusions of various medications and fluids.
The recall was initiated due to reported incidents of fluid leaks at the luer connection. The leaks have been confirmed to originate from, or near, the reservoir's clear-colored female luer connector. The affected lots are identified by the following codes: 20717525, 20717529, 20817502, 20817503, 20717509, 20717511, 20717512, 20717517, 20817500, and 20717530.
The products were distributed nationwide. Users should check their inventory for the specific part numbers and lot codes listed above. If the product matches the recalled items, it should be removed from service and returned to WalkMed, LLC according to the firm's instructions.
The recalled product
- Product
- Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is…
- Manufacturer
- WalkMed, LLC
- Hazard
- Affected units
- 25,920
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 (10)
- 20717525
- 20717529
- 20817502
- 20817503
- 20717509
- 20717511
- 20717512
- 20717517
- 20817500
- 20717530
Distribution
Distributed nationwide across the United States.
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