Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400;
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling Captivator Single-Use Polypectomy Snares and Captiflex Single-Use Polypectomy Snares due to incomplete pouch seals on the packaging. Users identified the incomplete seals before using the devices on patients. The recall affects 335,788 units distributed nationwide in the United States, along with international distribution. The affected products are identified by specific lot and batch numbers across multiple UPN codes and GTINs listed in the recall notice.
The recall notice does not specify a remedy or recommended action for consumers who may have affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Reason for recall: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. Distribution: US nationwide distribution. Quantity: 335,788 units total (Domestic: 222,882, Foreign: 112,906) Lot/code info: Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695, Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577, Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287, Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939, Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758, Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643 Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193, Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054, Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.