Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
Reported: March 10, 2021 Initiated: January 19, 2021 #Z-1170-2021
Product Description
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
Reason for Recall
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
- Distribution
- US nationwide distribution.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.. Recalled by Boston Scientific Corporation. Units affected: 335,788 units total (Domestic: 222,882, Foreign: 112,906).
Why was this product recalled? ▼
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 10, 2021. Severity: Moderate. Recall number: Z-1170-2021.
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