Reported Mar 28, 2018 · Terminated
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy…
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?
- Re-Entry" Malecot Nephrostomy Catheter Set
- Product NumberM0064101040
- GTIN08714729008446 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 Range3/27/2018 9/25/2021
- Batch
16852983189128642040411116969146189324662045838416987703191570722049174517078511193180432051772417159358193383992056707417248134195962982056707517672818196230642059396217780452197054782065886217910342197379202068299717960225198506922073579217976830199346312076925218100917200657142083024318106456201698342088429818172896201982632090929418280357202848282102705118398908203127272110191818821698203307662118152818876334
- Amount recalled
- 2224
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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