Reported Mar 28, 2018 · Terminated
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 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 NumberM0064101010
- GTIN08714729005278 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 - 10/4/2021
- Batch
1668234718705536206238191689377518773341206588611694340918876327206856591700357218898595207357911701712218987890207982261707506419058167208302401718485719515680208844801719271019900108209092961760350420094213209423651770388420261038210556831779736920312726211295801799064420401204211579531808449820458382211793911809591120491743212188491869189120517726
- Amount recalled
- 1716
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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