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.
This recall has been terminated (originally issued June 8, 2015).
- Company
- Smiths Medical Asd Inc
- Recall Initiated
- May 4, 2015
- Posted
- June 8, 2015
- Terminated
- January 20, 2016
- Recall Number
- Z-1730-2015
- Quantity
- 6,000 units
- Firm Location
- Dublin, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed to the states of KY, MN, NJ, UT, & WI.
Lot / Code Info
Product Reorder Number: 537235C; Lot #2761409
Root Cause
Process control
Action Taken
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.