OriGen recalls 6ml and 60ml syringes with yellowed tubing due to gamma sterilization issues. These syringes may not function safely for medical use. Affected units have specific reference numbers.
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.
OriGen is recalling 6ml and 60ml syringes that turned yellow after gamma sterilization. This could mean the syringes aren't safe for medical use as they weren't properly qualified for the accessory's intended purpose.
The syringes were gamma sterilized but the polypropylene resin change caused loss of gamma compatibility. This resulted in yellowed syringes that may not function safely for medical use.
Medical users who own the recalled syringes with yellowed tubing are most at risk. Patients using these syringes for medical purposes may face safety issues.
Check for yellowed syringes with reference numbers RF-T15 or 15-RF60-T. The syringes have specific lot numbers like V23277, V23278, V23639.
Look for yellowed syringes with reference numbers RF-T15 or 15-RF60-T.
The syringes turned yellow due to loss of gamma compatibility after sterilization, which is a result of design changes to the syringe barrels and polypropylene resin.
No, these syringes may not function safely for medical use because they weren't properly qualified for the accessory's intended purpose.
Check for reference numbers RF-T15 or 15-RF60-T with specific lot numbers like V23277, V23278, or V23639.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-1068-2024 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-1068-2024 from OriGen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
