Arrow recalls specific epidural catheterization kits due to potential dural puncture from LOR syringes, requiring immediate action to prevent complications.
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Arrow is recalling certain epidural catheterization kits because the LOR syringes may cause dural puncture, which can lead to serious complications like bleeding or infection. This recall affects medical professionals using these kits for epidural procedures.
The LOR syringes in the kits may fail, causing the needle to puncture the dura mater (the protective layer around the spinal cord). This can lead to bleeding, infection, or the need for a blood patch to seal the leak.
Medical professionals who use the recalled epidural catheterization kits for procedures are most at risk. Patients receiving epidural anesthesia during these procedures could also be affected.
Check for the product code CZ-05400-EPI on the kit. The affected lots are 71F19B0663, 71F19E2004, 71F19G2408, 71F19K2838, 71F19C0095, 71F19G0885, and 71F19H1697.
Identify the lot number on the kit to see if it matches the affected lots listed: 71F19B0663, 71F19E2004, 71F19G2408, 71F19K2838, 71F19C0095, 71F19G0885, or 71F19H1697.
Reach out to Arrow International Inc. for guidance on next steps if the kit is affected.
The LOR syringes in the kits may fail, causing dural puncture which can lead to bleeding, infection, or the need for a blood patch.
Check the lot number on the kit to see if it matches the affected lots. If it does, contact Arrow International Inc. for guidance.
Yes, dural puncture can cause bleeding, infection, or require a blood patch, which may lead to complications.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1194-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1194-2020 from Arrow. 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.