Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml… recallZ-1730-2015 · Smiths Medical Asd Inc · initiated May 4, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical Asd Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
FDA root cause category: Process control
What the company is doing
Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to be aware, including points of use. If these affected Extension Sets have been further distributed to other persons or facilities, please promptly forward the recipients a copy of this Urgent Medical Device Recall Notice.
Recall details
- Recall number
- Z-1730-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 4, 2015
- Posted by the FDA
- Jun 8, 2015
- Recalling firm
- Smiths Medical Asd Inc
- Quantity
- 6,000 units
- Product code
- FPA
- FDA submissions
- K831087
- Distribution
- Distributed to the states of KY, MN, NJ, UT, & WI.
Product description
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.
Code information (models, lots, serial numbers)
Product Reorder Number: 537235C; Lot #2761409
Other devices under the same FDA submission
3 devices cleared under K831087 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medex 537240PSIcu Medical, Inc. · Set, administration, intravascular5 reports
- Medex 536040Icu Medical, Inc. · Set, administration, intravascular5 reports
- Medex 53035Icu Medical, Inc. · Set, administration, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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