Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a
Summary
The FDA issued a Class II for Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tub by OriGen Biomedical, Inc.. Reason: Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropy.
Details
Source
Device Recall
External ID
Z-1068-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
Lot/Code Info: REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277, V23278, V23639; 15-RF60-T/10816203020571/V23281
Quantity Affected: 3613 Cases
Reason for Recall
Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
Distribution
US: FL, WA, NJ, MA, OH, CA, MD, TX, NE, ND OUS: GB, CA,NL,CH, PL, DE
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-19
Company
Austin, 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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (OriGen Biomedical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OriGen Biomedical, Inc. have FDA actions?
This is the only FDA action we have on record for OriGen Biomedical, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1068-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29