Z-2346-2012Class II

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest...

Name: Z-2346-2012 Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest...
Creator: Hospira, Inc.
Published: 2012-08-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-08-02 / Terminated / root cause: manufacturing process

FDA source

Hospira, Inc. began a recall of Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA... on 2012-08-02. FDA classified it as Class II and gives the reason as "Reports of leaking during filling and administration". 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-2346-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-02
Posted: 2012-09-10
Terminated: 2014-05-08
Recalling firm: Abbott Medical
Product: Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Product code: MEA Pump, Infusion, Pca
Reason for recall: Reports of leaking during filling and administration.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira sent an Urgent Device Field Correction letter dated August 3, 2012, to all affected customers. The letter identifed the product, the probem, and the action to be taken by the customer. Customers were instructed to first consider the use of Prefilled Morphine PCA Vials wherever possible. In some instances, the treating physician may require an alternative to morphine. Customers may continue using the affected product by following the instructions provided in the Correction Letter. Customers were asked to complete the attached Reply Form and fax it to 1-888-879-8144. For questions regarding this recall call 877-946-7747.
Quantity in commerce: unknown
Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.
Product codes and lots: The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2346-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2346-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

Product code MEA

K043256Class IIHospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03Hospira, Inc. / cleared 2004-12-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)