Angiodynamics recalls BioFlo 8F ports with incorrect sterile port assembly. This could lead to infection or other complications during medical use. Affected units include specific lot numbers and catalog codes.
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
Angiodynamics is recalling BioFlo 8F ports that were partially manufactured with the wrong sterile port assembly. Using these ports could increase the risk of infection or other complications during medical procedures.
The ports were manufactured with an incorrect sterile assembly (8F SL Xcela Plus Titanium Valved Non-Filled instead of 8F SL BioFlo Plastic Valved Non-Filled). This mismatch could lead to infection or other complications during medical procedures.
Patients using central venous access devices like BioFlo ports for long-term medical treatments are most at risk. Healthcare providers who use these ports for administering fluids or blood products may also be affected.
Check for the catalog number 44-021 and lot number 5363172 on the BioFlo port packaging. The product is sold under the brand name Angiodynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED.
Look for the catalog number 44-021 and lot number 5363172 on the BioFlo port packaging.
The recalled model is Angiodynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED with catalog number 44-021 and lot number 5363172.
The ports were partially manufactured with the incorrect sterile port assembly (8F SL Xcela Plus Titanium Valved Non-Filled instead of 8F SL BioFlo Plastic Valved Non-Filled).
Check the product packaging for the catalog number 44-021 and lot number 5363172. If you have these details, contact Angiodynamics for further instructions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0076-2019 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0076-2019 from Angiodynamics. 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.
