Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.
This recall has been terminated (originally issued September 8, 2010).
- Company
- Hospira Inc
- Recall Initiated
- March 26, 2010
- Posted
- September 8, 2010
- Terminated
- March 30, 2012
- Recall Number
- Z-2381-2010
- Quantity
- 28485 units
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.
Distribution
Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
Lot / Code Info
List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54.
Root Cause
Device Design
Action Taken
Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.