Reported Mar 28, 2018 · Terminated
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 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 NumberM0064101050
- GTIN08714729192268 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 Range1/14/2018 - 10/9/2021
- Batch
16661359187120752019826416749367187733402031273016806828188330322035021216861193188763382042513217108329189324712049174617184858190666952051772217207012191570752062408017226842192355472065311117263721193897562070343017303885194680612074069917624941195156812076925317642196195962992088429917785597198795462094236417858548199625582096866717960226199922142099556418095912200171612104694118196369200657172107113818220028201192172115795418351957201698322124125018484526
- Amount recalled
- 2614
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.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.