FDA recall Z-1169-2021

Product

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 for recall

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

Distribution

US nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-01-19

Report date

2021-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2021