FDA Device Recall Z-1370-2024: Alcon Research, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1370-2024.

Recall Res Number

Z-1370-2024

Recalling Firm / Manufacturer

Alcon Research, LLC

FEI Number

1000117501

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-02-21

Date Posted

2024-03-22

Date Terminated

N/A

Product Code

LRO

Event Number

94094

Product Quantity

886

Product Description 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

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.

Action Details 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.

Distribution Pattern US Nationwide distribution in the states of OH, WV.

Code Information / Serial Numbers 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

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Medical Device Recall: Z-1370-2024

Recall Parameters & Description

Related Establishments / Registrations

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