Reason: Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Distributed: US and Great BritainReason: Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Distributed: US and Great BritainReason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Distributed: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Distributed: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Distributed: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.Reason: Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
Distributed: Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.Reason: When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
Distributed: USA Nationwide DistributionReason: Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
Distributed: Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.Reason: DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.
Distributed: Worldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.Reason: Incorrect transmission of laboratory results.
Distributed: Worldwide Distribution - USA, including Puerto Rico and the country of Canada.