BALT USA recalls Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to pouch label not matching carton labels. This mismatch may cause confusion during medical procedures.
Product pouch label does not match up with carton label
BALT USA is recalling two models of Optima Coil System used in endovascular procedures because the product pouch label does not match the carton label. This mismatch could lead to confusion during medical procedures, potentially affecting patient safety.
The product pouch label does not match the carton label, which could lead to confusion during medical procedures. This mismatch might cause the wrong model to be used, potentially affecting patient safety.
Medical professionals using the Optima Coil System for endovascular procedures are most at risk. Patients receiving these procedures may be affected if the label mismatch causes errors.
Check for model numbers OPTI0208CSS10 or OPTI0308CSS10 on the product pouch and carton. The lot numbers are F220601068 and F220601089 respectively.
Verify that the product pouch label matches the carton label for model numbers OPTI0208CSS10 or OPTI0308CSS10.
The product pouch label does not match the carton label, which could cause confusion during medical procedures.
Check that the pouch label matches the carton label for model numbers OPTI0208CSS10 or OPTI0308CSS10. If they don't match, contact BALT USA for guidance.
The recall is for label mismatch, which may cause confusion but does not indicate a risk of serious injury in normal use.
We’ve drafted a message you can send BALT to request your refund or repair — edit it as you like.
Subject: Recall Z-0103-2023 — BALT BALT Hello, I own a BALT that is covered by recall Z-0103-2023 from BALT. 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.
