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
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 14,145 NC Emerge Monorail PTCA Dilatation Catheters (3.50MM, catalog number H7493926708350) that were sterilized using ethylene oxide. The catheters were distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada. The recall affects multiple lot numbers with expiration dates ranging from November 2019 through July 2021.
The catheters are being recalled because they may have missed the hydrophilic coating step during manufacturing, which creates a lubricious (slippery) surface on the devices. The source document does not specify what consumers or healthcare facilities should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada. Quantity: 14,145 devices total 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.