Prytime Medical recalls ER-Reboa Plus Catheters with potential incorrect balloon marking, risking procedure delays or patient injury. Affected units have specific model and lot numbers.
There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
Prytime Medical is recalling ER-Reboa Plus Catheters that may have incorrectly marked balloon sizes. This could cause procedure delays or patient injury during emergency medical procedures.
The catheter may have incorrect balloon markings, which could lead to improper sizing during emergency procedures. This might cause delays in critical treatments or injury to the patient.
Healthcare professionals using the catheter for emergency procedures are most at risk. Patients undergoing emergency hemorrhage control may be affected if the catheter is used incorrectly.
Check for the model number ER7232PLUS and lot number 205936 on the catheter packaging. The product is intended for emergency use only and requires specific medical training.
Look for model number ER7232PLUS and lot number 205936 on the catheter packaging.
The catheter may have incorrectly marked balloon sizes, which could cause procedure delays or patient injury during emergency medical procedures.
Check the model number and lot number on the packaging. If it matches ER7232PLUS and lot 205936, contact Prytime Medical for further instructions.
The recall states there is a potential for procedure delays or injury, but the exact risk level is not specified in the notice.
We’ve drafted a message you can send Prytime Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0716-2021 — Prytime Medical Prytime Medical Hello, I own a Prytime Medical that is covered by recall Z-0716-2021 from Prytime Medical. 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.