FDA recall Z-1852-2021

Anodyne Surgical · Class II · device

Product

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

Reason for recall

The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.

Distribution

Worldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.

Key facts

Status
Terminated
Initiation date
2021-04-21
Report date
2021-06-23
Termination date
2022-05-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1852-2021