Z-1625-2014 Class II Terminated
Recalled by Hospira Inc.
— Lake Forest, IL
FDA device recall Z-1625-2014 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: 1,613,775 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
- 1,613,775 sets
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
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. 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1625-2014
- 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.