SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Baxter Corporation Englewood
Class I - Dangerous
Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
Class I - Dangerous
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
LAP of America Laser Applications
Class I - Dangerous
While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.
ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Class I - Dangerous
Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
Beckman Coulter
Class I - Dangerous
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Class I - Dangerous
Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
NIPRO Safe Touch Safety Scalp Vein Set
Nipro Medical
Class I - Dangerous
There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.