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.
This recall is currently active, issued January 19, 2021. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- January 19, 2021
- Recall Number
- Z-1169-2021
- Quantity
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Distribution
US nationwide distribution.
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
Root Cause
Process change control
Action Taken
On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile.