FDA Recall
Open, Classified
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.
Recall: Z-1169-2021
·
Initiated January 19, 2021
Recall
- Recall Number
- Z-1169-2021
- Event Number
- 87221
- Firm
- Boston Scientific Corporation
- FEI Number
- 3005099803
- Product Code
- FDI
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- January 19, 2021
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234
Description
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.
Reason
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Action
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.
Distribution
US nationwide distribution.
Quantity
335,788 units total (Domestic: 222,882, Foreign: 112,906)