ICU Medical recalls 5" smallbore infusion sets with incorrect spin collars that could cause disconnection during use. Affected units include Item B99066, lot 35490: stop using and contact for replacement.
The infusion sets were manufactured with an incorrect spin collar.
ICU Medical is recalling 5-inch smallbore infusion sets that were manufactured with an incorrect spin collar. This could cause the sets to disconnect during use, potentially leading to medical complications for patients.
The incorrect spin collar may cause the infusion set to disconnect during use. This could lead to interruption of fluid administration to patients, potentially causing medical complications.
Healthcare professionals and patients using these infusion sets for medical treatments. Those with the specific item number B99066 and lot number 3549002 are most at risk.
Check for the product name '5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case' and item number B99066. The lot number 3549002 is also associated with this recall.
Discontinue use of the affected infusion sets as they may disconnect during medical procedures.
The item number for this recall is B99066.
Lot number 3549002 is associated with this recall.
Check for the product name '5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case' and item number B99066.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1346-2018 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.
