Recall Z-1852-2021— Anodyne Surgical

Class II · Terminated

Class II FDA medical device recall by Anodyne Surgical, initiated 2021-04-21, terminated 2022-05-27. FDA's recall record names no specific 510(k) clearance for this event. 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: The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula..

Recalling firm
Anodyne Surgical
Classification
Class II
Status
Terminated
Initiated
2021-04-21
Terminated
2022-05-27
Firm location
Saint Charles, MO, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.