Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Fores
FDA device recall Z-0070-2013 · posted 2012-10-19 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
- Action taken
- Hospira sent an Urgent Device Correction letter dated August 29, 2012, to all affected customers. Customers have been informed of reports that the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. The users were instructed to complete and fax the enclosed reply card to 1-888-943-5180 or email it to Hospira194@stericycle.com indicating the number of infusers at the facility and if they notified their users throughout the facility. Wholesalers were asked to notify their customers. If they have further distributed the affected product, they should notify their accounts and ask them to contact Stericycle at 1-877-272-6141 to receive a reply form. For questions regarding this recall call 224-212-2000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 14,067 units
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
- Date initiated
- 2012-08-29
- Date posted
- 2012-10-19
- Date terminated
- 2017-03-15
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYMBIQ INFUSION AND ADMINSTRATION SET (K110901) | Hospira, Inc. | 2012-03-05 |
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |