Class II Recall

SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 1801

Summary

The FDA issued a Class II for SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak S by Alcon Research, LLC. Reason: Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgica.

Details

Source

Device Recall

External ID

Z-1370-2024

Action Date

2024-04-03

Status

Ongoing

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

Lot/Code Info: 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

Quantity Affected: 886

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.

Distribution

US Nationwide distribution in the states of OH, WV.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-21

Company

Alcon Research, LLC

Houston, TX

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Alcon Research, LLC has 66 FDA actions in our database, including 66 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Alcon Research, LLC have FDA actions?

Alcon Research, LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1370-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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