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U.S. Department of Health and Human Services

Class 2 Device Recall Hydrodissection Cannula (Chang)

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 Class 2 Device Recall Hydrodissection Cannula (Chang)see related information
Date Initiated by FirmApril 21, 2021
Create DateJune 11, 2021
Recall Status1 Terminated 3 on May 27, 2022
Recall NumberZ-1852-2021
Recall Event ID 87795
Product Classification Cannula, ophthalmic - Product Code HMX
ProductHydrodissection 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
Code Information 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
Recalling Firm/
Manufacturer		 Anodyne Surgical
804 Corporate Centre Dr
Saint Charles MO 63304-8684
For Additional Information ContactValerie Anderson
636-447-1010
Manufacturer Reason
for Recall		The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
FDA Determined
Cause 2		Employee error
ActionThe firm initiated the recall by email on 04/21/2021. The letter explained the issue and requested the return of the product.
Quantity in Commerce8452 units
DistributionWorldwide distribution - US Nationwide distribution in the states of IL, NJ, TX, MO, CA, PA, WA, and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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