Entry system accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
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: Scored 3 under the risk-of-harm criterion: a failed sterile barrier on a surgical accessory creates an infection risk, and no injuries are reported.
Plain-English summary
Accessory devices for Alcon Unity and Constellation surgical consoles are being recalled. The affected items identified in the record include catalog number 8065000356, the 27GA HP Entry System 4 mm, with the firm referring to a fuller affected product list.
The recall follows incomplete seals in the pouch which provides the sterile barrier.
The recall covers 1,632 units, including UDI-DI 00380650003560 from lot 17CFND. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
An incomplete seal means the sterile barrier may not have held. Facilities holding affected lots should quarantine them and follow Alcon's instructions.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1…
- Manufacturer
- Alcon Research LLC
- Affected units
- 1,632
Distribution
Part of a larger recall action
This product is one of 5 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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