Smiths Medical Recalls Low Volume Extension Sets Due to Tubing Defect
Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.
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 involves a medical device with a structural defect (under-sized tubing) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 6,000 units of Low Volume Extension Sets, 72' w/Clamp FLL/MLL APV=1.3ml. The recall involves Product Reorder Number 537235C and Lot #2761409. These sterile, latex-free, single-use medical devices are used to administer fluids and drugs intravenously.
The recall was initiated because under-sized tubing was used in the production of this specific lot. The affected units were distributed to the states of Kentucky, Minnesota, New Jersey, Utah, and Wisconsin.
Healthcare facilities and consumers should stop using the affected product and contact Smiths Medical for further instructions or a return.
The recalled product
- Product
- Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
- Manufacturer
- Smiths Medical Asd Inc
- Affected units
- 6,000
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)
- Product Reorder Number: 537235C
- Lot #2761409
Distribution
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