Hospira, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2346-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 2, 2012

Date Posted: September 19, 2012

Recall Number: Z-2346-2012

Event ID: 62909

Reason for Recall:

Reports of leaking during filling and administration.

Status: Terminated

Product Quantity: unknown

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated