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; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
Reported: March 10, 2021 Initiated: January 19, 2021 #Z-1168-2021
Product Description
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; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
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 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; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.. 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-1168-2021.
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