Warmer, Irrigation Solution

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2017-01-26TerminatedLabeling mix-ups

  NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.

  Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-10-30TerminatedPackaging

  Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.

  Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

• 2015-09-18TerminatedPackage design/selection

  Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

  The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.