FDAClass IIJune 23, 2021

Hydrodissection Cannula recall

Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168…

Why was Hydrodissection Cannula recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF 7018, Lot Numbers: 201157-08 REF AS-7638, Lot Numbers: 210071-001, 210071-002 REF 7018NS, Lot Numbers: 210143-002 REF K20-3168, Lot Numbers:201108-005, 201108-017, 201108-018, 201154-007 REF 104910, Lot Numbers: 201144-002, 2010006-02, 210039-002, 210070-0001, 210080-01, 210127-001 REF CA7800, Lot Numbers: 201067-003, 201068-020 REF AX14784-BULK, Lot Numbers: 200580-006 REF RX2300NS, Lot Numbers: 200359-003 REF RX2300, Lot Numbers: 210142-002

Product
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168…
Recalling firm
Anodyne Surgical
Quantity
8452 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.
Recall date
June 23, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls