Z-0372-2014Class II

* 1) SYMBIQ One-Channel Infuser; * 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by...

Name: Z-0372-2014 *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by...
Creator: Hospira Inc.
Published: 2013-08-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-08-28 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of *** 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... on 2013-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0372-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Posted: 2013-11-20
Terminated: 2016-11-07
Recalling firm: Abbott Medical
Product: *** 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.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Hospira, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 28, 2013 to its customers. Hospira contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response, tracking, returns, effectiveness checks and destruction of returned product starting on August 28, 2013. The letter described the product, problem and actions to be taken. Customers were instructed to: 1) complete and return the attached reply form via fax to 1-866-470-3291 or e-mail to [email protected], even if you do not currently have the affected batteries; 2) contact Stericycle at 1-877-779-7810 (M-F, 8am - 5pm ET) if they require additional response forms; and, 3) return any affected batteries upon receipt of the new (correct) replacement batteries to Stericycle. Customers are also instructed to forward the recall information to any accounts that they may have shipped the affected batteries to and have them contact Stericycle to recieve a reply form and return label. For further inquiries, please contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 6, availabel 24 hours a day/7 days per week.
Quantity in commerce: 59 batteries
Distribution: US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
Product codes and lots: *** 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0372-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20

Product code FRN

K110901Class IISymbiq Infusion and Adminstration SetHospira, Inc. / cleared 2012-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)