Alcon Custom Pak surgical kits may have damaged lidding compromising sterility
Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.
What this means for you
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: Risk-of-harm product: possible compromise of the sterile barrier on a surgical kit, with no infection reported in the source.
Plain-English summary
Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled across the catalog and lot numbers listed in the manufacturer's affected product list. The action covers 15,557 kits.
According to the manufacturer, some units within specific lots were potentially damaged during the manufacturing process, with the area of damage within the same area of the lidding. The manufacturer states that while the damage in the lidding is visibly noticeable, the recall is being made due to the risk of sterility being compromised. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the manufacturer's affected product list and follow the instructions issued by Alcon.
The recalled product
- Product
- Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
- Manufacturer
- Alcon Research LLC
- Affected units
- 15,557
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 (7)
- ST JOHN'S 380655116074 14540-08 177H6V CDN-CVS VIT 10K 25G+ HSC
- ST JOHN'S 380655116074 14540-08 178DYX CDN-CVS VIT 10K 25G+ HSC
- ST JOHN'S 380655116074 14540-08 178FDJ CDN-CVS VIT 10K 25G+ HSC
- ST JOHN'S 380655116074 14540-08 17AC44 CDN-CVS VIT 10K 25G+ HSC
- ST JOHN'S 380655116074 14540-08 17AE5U CDN-CVS VIT 10K 25G+ HSC
- W_O SLIT) KITANO HO 380655198353 17923-05 17CH88 J-CVS CAT PAK (W_IA
- W_O SLIT) KITANO HO 380655199688 19037-05 17C991 J-COMB 25G20K (W_IA
Distribution
Part of a larger recall action
This product is one of 3 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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