| Class 2 Device Recall Alcon Custom Pak Surgical Procedure Pack |  |
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
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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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LRO
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