Recall Z-1370-2024
Alcon Research, LLC · initiated February 21, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1370-2024
- Initiated
- February 21, 2024
- Posted by FDA
- March 22, 2024
- Product code
- LRO – General Surgery Tray
- Quantity
- 886
- Distribution
- US Nationwide distribution in the states of OH, WV.
- Recalling firm
- Alcon Research, LLC, Houston, TX