Reported Mar 28, 2018 · Terminated
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is…
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?
- Percutaneous Access Set
- Product NumberM0064201150
- GTIN08714729009757 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 Range12/10/2017 - 10/29/2021
- Batch
82 of 82 codes
166027571798918919103005166328041800005119156402166682321807102819272679166877251818790819323232167019051823892619338380167257481831253919374391167460211834720219419431167681701840371119510783167696871845352919543444167910471846722419596296168133261851181619622910168611851852240119652445168867961863111919672586169118891870224819824542169187701870224919884752169310221870583620001153169310711878019520091268169645251880008820118753171430461881862520198261172273801882039120288613
- Amount recalled
- 3762
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.