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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Custom Pak Surgical Procedure Pack

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  Class 2 Device Recall Alcon Custom Pak Surgical Procedure Pack see related information
Date Initiated by Firm February 21, 2024
Date Posted March 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1370-2024
Recall Event ID 94094
510(K)Number K880961  
Product Classification General surgery tray - Product Code LRO
Product SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15
Code Information Product/Lot/Expiration/UDI-DI: 18018-06/15T707/02/28/2025/380655148440, 3865-44/15T2RC/02/28/2025/380655148150, 5675-76/15T70E/02/28/2025/380655148174, 13554-11/15V4RC/02/28/2025/380655143711, 18018-06/15V3E0/02/28/2025/380655148440, 15190-16/JZ5179517/06/30/2024/380655148303, 15190-16/JZ5179519/06/30/2024/380655148303, 15190-16/JZ5179521/06/30/2024/380655148303, 15190-16/JZ5179523/06/30/2024/380655148303, 15190-16/JZ5179529/06/30/2024/380655148303, 13554-11/15TAUD/01/31/2026/380655143711, 5918-39/15TE5F/02/28/2025/380655149140, 15190-16/15THVA/04/30/2025/380655148303, 15190-16/15TNXJ/04/30/2025/380655148303, 9208-66/15V8CU/04/30/2025/380651693326, 9208-66/15XVDD/05/31/2025/380651693326, 5675-76/JZ5180811/06/30/2024/380655148174, 5918-39/JZ5180812/06/30/2024/380655149140, 9208-66/JZ5180332/03/31/2025/380651693326, 15190-16/JZ5180856/05/31/2025/380655148303, 9065-25/JZ5187593/11/30/2025/380651682849, 5918-39/JZ5187260/06/30/2024/380655149140, 16066-15/JZ5190913/07/31/2025/380655149683, 16066-15/JZ5191891/07/31/2025/380655149683 Bulb Syringe lots: 96922110001 or 96923100001
Recalling Firm/
Manufacturer		 Alcon Research, LLC
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact
713-668-9100
Manufacturer Reason
for Recall		 Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 2/21/24, correction notices were mailed to customers who were asked to do the following: 1) Review your inventory to determine if you have any affected product within your facility. 2) If you have any affected Custom Pak lots in inventory, please use the included stickers to label any affected product. If you have previously reshelved either of the affected Medline Bulb Irrigation Syringe lots, dispose them. 3) All components inside the Pak are intended to be used only for one specific surgical case and should be discarded at the end of the surgical case. 4) Forward the correction notice to all departments within your organization who may be in possession of affected product; and any other organization to which this product may have been transferred. 5) Complete and return the response form via email to Market.Actions@Alcon.com Customers with questions or concerns can call the firm at 1-800-862-5266.
Quantity in Commerce 886
Distribution US Nationwide distribution in the states of OH, WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES
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