Recall Z-1627-2014 · GBX Catheter, Irrigation

Hospira Inc.

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

Date	May 16, 2014 (initiated Mar 25, 2014)
Status	Terminated
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
Root cause	Process design
Action	Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated March 25, 2014 to all affected customers. The letter included instructions for the direct accounts to: 1) check their inventories and quarantine any of the affected products; 2) complete and return the attached reply form to the fax number or e-mail address on the form; 3) inform potential users of these products of this recall; 4) return the affected products to Stericycle using the labels provided with the letter (additional labels or reply forms can be obtained by calling Stericycle at 877-377-5128, Monday - Friday, 8:00 AM - 5:00 PM
Quantity	29,380 sets
Distribution	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
FDA record	Open on fda.gov

510(k) clearances named in this recall

K841362

TIDAL DISTENSION IRRIGATION SET
Abbott Laboratories, Aug 2, 1984