ICU Medical recalls 6.5" smallbore infusion sets with incorrect spin collars. These devices may cause improper connections during medical use. Affected units include specific lot numbers and model A1009-NS.
The infusion sets were manufactured with an incorrect spin collar.
ICU Medical is recalling 6.5-inch smallbore infusion sets that were manufactured with an incorrect spin collar. This could lead to improper connections during medical procedures, potentially causing complications for patients.
The incorrect spin collar may not function properly during medical procedures, leading to improper connections. This could cause issues with fluid administration or patient safety.
Healthcare professionals using these infusion sets for patient care are most at risk. Patients receiving treatment with the recalled sets may face complications if the spin collar fails.
Check for the model number A1009-NS on the label. The product was sold with lot numbers 3474877 and 3481246, and includes 500 units per case.
Look for the model number A1009-NS and lot numbers 3474877 or 3481246 on the label.
The model number is A1009-NS.
Lot numbers 3474877 and 3481246 are affected.
Each case contains 500 units.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1342-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1342-2018 from ICU 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.
