Medical equipment, implants, and diagnostic devices
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for
Intel-GE Care Innovations
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
Product coatings require 510K approval.
Unimed Surgical Products
Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
Product coatings require 510K approval.
Product coatings require 510K approval.
Chicago X-Ray Systems
The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.
Product coatings require 510K approval.
Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.
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.
Product coatings require 510K approval.
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.
Product coatings require 510K approval.
Technidata S.A.
Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.
Medical Information Technology
Incorrect transmission of laboratory results.
Product coatings require 510K approval.