ClearanceBrief
Recall Z-1852-2021 ยท HMX Cannula, Ophthalmic

Anodyne Surgical

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

DateApr 21, 2021
StatusTerminated
ReasonThe product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Root causeEmployee error
ActionThe firm initiated the recall by email on 04/21/2021. The letter explained the issue and requested the return of the product.
Quantity8452 units
DistributionWorldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.