Reported May 28, 2014 · Terminated
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For…
Hospira Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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 UsageFor Constant or Intermittent Bladder Irrigation
- Lot codes and dates
- List No. 6544-04-01 (6544-01)
- Lot Numbers
64 of 64 codes
13107NS13108NS13171NS13172NS15141NS15142NS15143NS16113NS16114NS16115NS16116NS16174NS16175NS16176NS17134NS18112NS19130NS19131NS19132NS20119NS20120NS20121NS21130NS21131NS21207NS22144NS22145NS23107NS23108NS23109NS23110NS23111NS23112NS24194NS24204NS25133NS25254NS27110NS27111NS27155NS28192NS28271NS28272NS29097NS29170NS29171NS30197NS30198NS30199NS30200NS31044NS31045NS32231NS32232NS32391NS33328NS34170NS34170NS34171NS34287NS
- Amount recalled
- 1,613,775 sets
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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