Z-0372-2014 Class II Terminated
FDA device recall Z-0372-2014 was initiated by Hospira Inc. on Aug 28, 2013 and is designated Class II. Reason for recall: Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers. The recall status is terminated (terminated Nov 7, 2016). Affected quantity: 59 batteries.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2013
- Initiation Date
- Aug 28, 2013
- Termination Date
- Nov 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 batteries
Product Description
*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.
Reason for Recall
Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.
Distribution Pattern
US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
Code Information
*** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0372-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026