Recall Z-1627-2014— Hospira Inc.

Name: FDA recall Z-1627-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2014-03-25, terminated 2016-12-06. It names one FDA 510(k) clearance: K841362. Product: 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: 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.

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Terminated: 2016-12-06
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K841362 — TIDAL DISTENSION IRRIGATION SETAbbott Laboratories·cleared 1984-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.