Hospira Inc.: Medical Device Recall in 2014 - (Recall #: Z-1626-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems

Product Classification:

Class II

Date Initiated: March 25, 2014

Date Posted: May 28, 2014

Recall Number: Z-1626-2014

Event ID: 68129

Reason for Recall:

The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea

Status: Terminated

Product Quantity: 167,574 sets

Code Information:

List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS

Distribution Pattern:

Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates

Voluntary or Mandated:

Voluntary: Firm initiated