Home / Recalls / Hospira Inc. / Z-1627-2014

Z-1627-2014 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-1627-2014 was initiated by Hospira Inc. on Mar 25, 2014 and is designated Class II. 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… The recall status is terminated (terminated Dec 6, 2016). Affected quantity: 29,380 sets.

Recall Details

Product Type: Devices
Report Date: May 28, 2014
Initiation Date: Mar 25, 2014
Termination Date: Dec 6, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29,380 sets

Product Description

LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures

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

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

Code Information

List No. 15239-04-01 (15239-01); Lot Numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, 31041NS

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1627-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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