Recall Z-1852-2021
Anodyne Surgical · initiated April 21, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
FDA-determined cause: Employee error
Action taken
The firm initiated the recall by email on 04/21/2021. The letter explained the issue and requested the return of the product.
Details
- Recall number
- Z-1852-2021
- Initiated
- April 21, 2021
- Terminated
- May 27, 2022
- Product code
- HMX – Cannula, Ophthalmic
- 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.
- Recalling firm
- Anodyne Surgical, Saint Charles, MO