SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged c
FDA device recall Z-0925-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in
- Action taken
- The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated January 22, 2014 to customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the listed lot numbers, contact CareFusion for a replacement of the affected lots, and if you have inventory of the listed products immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. All recalled product should be returned directly to the distributor from whom it was purchased. If you have any question, contact your distributor directly or call the CareFusion Support Center at numbers below. For recall related questions, customers are instructed to contact CareFusion Support center at (888) 562-6018. For adverse event reports, customers are instructed to contact Customer advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. For technical questions regarding the Alaris System, customers are instructed to contact technical support at (888) 812-3229.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
- Date initiated
- 2014-01-22
- Date posted
- 2014-02-03
- Date terminated
- 2015-08-06
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (K960280) | Y | 1996-04-04 |