Reported May 28, 2014 · Terminated
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible…
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; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use
- Hospira Product UsageFor use in transurethral resection procedures
- Lot codes and dates
- List No. 6543-04-01 (6543-01)
- Lot Numbers
13106NS13170NS13251NS14261NS14262NS15139NS16117NS17131NS17132NS17184NS18110NS18111NS18182NS19133NS20122NS20123NS20124NS20205NS22146NS22147NS22148NS22149NS23103NS23104NS23105NS23106NS24156NS25130NS25131NS27109NS27253NS27286NS28136NS28137NS29094NS29095NS29096NS30194NS30195NS30196NS31042NS31043NS32229NS32230NS33138NS33139NS33140NS34286NS35117NS
- Amount recalled
- 1,109,321 set (US); 15,113 sets (Foreign)
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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