Arrow recalls EPIDURAL CATHETERIZATION KIT (Product Code FR-05501-04) due to potential LOR syringe failures causing dural puncture and blood patches. Affected lots listed in the recall notice.
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 a specific epidural catheterization kit because its LOR syringes might fail, leading to dural puncture and requiring blood patches. This could cause serious complications during spinal procedures.
The LOR syringes in the kit can fail during use, potentially puncturing the dura (spinal membrane). This may require a blood patch to seal the leak, which can cause serious complications like infection or neurological issues.
Healthcare professionals using the kit for spinal procedures are most at risk. Patients undergoing epidural anesthesia may also be affected if the kit is used improperly.
Check the product code FR-05501-04 on the kit. Affected lots include specific batch numbers listed in the recall notice.
Review the kit's lot numbers to see if they match the affected lots listed in the recall notice.
The LOR syringes in the kit can fail, potentially causing dural puncture and requiring a blood patch during spinal procedures.
Check the product lot numbers against the affected lots listed in the recall notice. If you have an affected lot, contact Arrow for further instructions.
Yes, dural puncture can lead to complications like infection or neurological issues, requiring a blood patch.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1197-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1197-2020 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.