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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
Recall Number Z-1625-2014
Classification Class II
Code Info List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS
Product Distributed Qty 1,613,775 sets
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-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.

Event Detail

Event Id 68129
Product Type Devices
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-25
Initial Firm Notification of Consignee or Public Letter
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