MEDLINE INDUSTRIES, LP – Northfield Recall 94537
Description: MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
MEDLINE INDUSTRIES, LP – Northfield Recall 94537 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1938-2024 |
Event ID | 94537 |
Event Description | MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI. |
Quantity | 5,075,234 syringes |
Recall Reason | It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health. |
Device Classification | 20240612 |
Device Code Info | UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX |
Center Classification Date | 20240531 |
Recall Initiation Date | 20240422 |
Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
Initial Notification | Letter |
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