medical Class II Updated 2019-12-04

Boston Scientific Corporation recalls NC Emerge Monorail PTCA Dilatation Catheter. Sterilized usi

Recalled Product

NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EMERGE MR US 3.25MM X 12MM; 9. REF/Catalog No. H7493927612350, NC EMERGE MR OUS 3.50MM X 12MM; 10. REF/Catalog No. H7493926712400, NC EMERGE MR US 4.00MM X 12MM; 11. REF/Catalog No. H7493927612500, NC EMERGE MR OUS 5.00MM X 12MM; 12. REF/Catalog No. H7493927615270, NC EMERGE MR OUS 2.75MM X 15MM; 13. REF/Catalog No. H7493926715300, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.

Hazard / Issue

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot / GTIN Number / Use By: 1. 21333639 / 8714729846284 / 2019-11-03. 2. 23808016 / 8714729847007 / 2021-05-16. 3. 21865055 / 8714729847021 / 2020-03-14. 4. 24119885 / 8714729847076 / 2021-07-16. 5. 23541260 / 8714729846376 / 2021-03-25. 6. 22119751 / 8714729847090 / 2020-05-14. 7. 22294873 / 8714729846383 / 2020-06-24. 8. 24119876 / 8714729846406 / 2021-07-21. 9. 23479019 /8714729847137 / 2021-03-12 , 23874443 / 8714729847137 / 2021-05-29, 24133485 / 8714729847137 / 2021-07-18. 10. 23998680 / 8714729846437 / 2021-06-23. 11. 22690879 / 8714729847175 / 2020-09-21. 12. 23511693 / 8714729847236 / 2021-03-19, 23584725 / 8714729847236 / 2021-04-02. 13. 21327739 / 8714729846529 / 2019-11-02. 14. 23436304 / 8714729847243 / 2021-03-04, 23541268 / 8714729847243 / 2021-03-25. 15. 23931831 / 8714729847250 / 2021-06-10. 16. 23998683 / 8714729846543 / 2021-06-21.
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