Reported Mar 28, 2018 · Terminated
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter…
Boston Scientific Corporation
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: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Malecot Nephrostomy Catheter Set
- Product NumberM0064101000
- GTIN08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage
- and is indicated for the followingDiagnostic
- Indications" Antegrade pyelography " Pressure/perfusion study (Whitaker
- test) Therapeutic Indications" Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
- Lot codes and dates
- Expiration Date Range1/22/2018 - 10/24/2021
- Batch
166825151835195919879547169549041851806520221526170236241866284920491742171746771868995820593965175479011877315820703428176342241882169920798225177973701889859220824604178810311910357020872724179906431913481720995561180065791918506621055681181417651923554621101919182803561936867921179390
- Amount recalled
- 1480
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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