Boston Scientific Corporation: Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220;

Is my product affected?

Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.

• UPC 08714729855934
• UPC 08714729861263
• UPC 08714729855903
• UPC 08714729861294
• UPC 08714729861300
• UPC 08714729861317
• UPC 08714729861348
• UPC 08714729861324

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling Captivator II Single-Use Polypectomy Snares due to incomplete seals found on device packaging pouches. Users discovered the incomplete seals before using the devices in patients. The recall affects approximately 335,788 units distributed nationwide in the United States, with additional units distributed internationally. The affected devices are identified by specific lot and batch numbers across multiple outer box and inner pouch combinations.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Details from the source

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: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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