Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic 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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic 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
Product Codes/Lot Numbers:
Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1104-2018
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