FDA recall Z-2229-2021

Product

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

Reason for recall

Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).

Distribution

US Nationwide Distribution - CA, CO, MI Foreign: Australia

Key facts

Status

Completed

Initiation date

2021-01-12

Report date

2021-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hudson, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2229-2021