FDA Device Recalls

Class IIITerminated

Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664 For use with the conserve metal head

MicroPort Orthopedics Inc.

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

June 21, 2016 · DeviceView details →

The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.

Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head

Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head

Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head

Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head

Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.