Alcon anti-reflux valve tubing breakage recall due to improper use
Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a Class III medical device with no reported injuries, deaths, or serious harm. The issue is breakage of the Anti-Reflux Valve tubing due to improper use, with the primary corrective measure being changes to labeling. Per the rubric, with no Class I/II classification and no documented injuries, the appropriate severity is Moderate.
Plain-English summary
Alcon Research LLC is issuing a recall of its Custom-Pak anti-reflux valve (ARV) tubing due to reported breakage that resulted from improper use. The manufacturer has implemented changes to the labeling to address the issue.
The affected products include multiple surgical kits (3486 total) containing the ARV tubing across several lot numbers distributed to Delaware, Illinois, and Oklahoma. The recall targets the tubing component specifically, as the breakage was attributed to improper use rather than manufacturing defects.
Consumers and healthcare facilities using these surgical kits should cease use immediately and follow the updated labeling instructions provided by Alcon. The recall focuses on correcting the labeling to prevent future incidents of tubing breakage during use. No injuries or fatalities have been reported associated with this recall, and the corrective action centers on improved warning/directionality rather than hardware redesign.
The recalled product
- Product
- a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC…
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 3,486
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)
- UDI-DI: +H5301ALCON1CPAK10 a) Custom Pak # 15340-11: (Lot
- Exp) JZ5221212
- 2025-02-28
- JZ5221710
- 16PETC
- 2025-03-31
- 1704TA
- 16TENC
- 2025-07-31
- 16UDE9
- 16WL8F
- 16X6FE
- 2025-07-31. b) Custom Pak # 6557-59: (Lot
- Exp) 2326720H
- 2022-02-13
- 2333628H
- 2022-05-14. Custom Pak # 6557-60: (Lot
- Exp) JZ5020496
- 2020-10-31
- JZ5033702
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