Hydrodissection Cannula Recall Due to Residue at Tip
Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a manufacturing defect resulting in residue contamination on a surgical instrument. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
Anodyne Surgical has recalled the Hydrodissection Cannula (Chang), 27 gauge. The product is distributed under multiple brand and reference numbers, including ASICO, Katena, MSI, Accutone, and Walcott Rx Products.
The recall is due to the potential presence of a yellowish-brown or greenish-brown residue at the tip of the cannula.
Approximately 8,452 units were distributed worldwide. Confirmed distribution includes the United States (Illinois, New Jersey, Texas, Missouri, California, Pennsylvania, and Washington) and Canada.
The recalled product
- 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…
- Manufacturer
- Anodyne Surgical
- Affected units
- 8,452
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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