Medical device recalls for February 2013

March 4, 2013 by Arezu Sarvestani

Class I and class II recalls issued by the Center for Devices & Radiological Health in February 2013.

Intel-GE Care Innovations LLC    Feb-23-2013       Care Innovations QuietCare-Networked product - QuietCare-Networked product; Facility Server/model: QC101601; The QuietCare system is intended  to detect and analyze residents' movements.                Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated; a defect in the implementation of the Wander and Night Motion ADLs was discovered.

Medacta Usa Inc              Feb-23-2013       Versafitcup Total Hip System-Impacting Ring - Versafitcup Impacting RingModel Number: 01.26.10.0133 (46mm); 01.26.10.0134 (48mm); 01.26.10.0135 (50mm); 01.26.10.0136 (52mm); 01.26.10.0137 (54mm); 01.26.10.0138 (56mm); 01.26.10.0139 (58mm); 01.26.10.0140 (60mm); 01.26.10.0141 (62mm); 01.26.10.0142 (64mm).Designed for cementless use in total hip arthroplasty.   Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases.  This could result in surgical delay potentially increasing possible complications under anesthesia; having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.

Cellestis Inc        Feb-26-2013       QuantiFERON - TB Gold TB High Altitude (HA)Blood Collection Tubes - Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.;1200 pcs in total. Product Usage:  QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6; CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.      Cellestis is recalling QuantiFERON?? - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

Cellestis Inc        Feb-26-2013       QuantiFERON - TB Gold TB High Altitude (HA)Blood Collection Tubes - VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.;1200 pcs. in total;Product Usage:  QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6; CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.   Cellestis is recalling QuantiFERON?? - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

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