Class I - Dangerous
BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Class I - Dangerous
The voluntary recall is due to the needle set not meeting its specifications.
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
Centurion Medical Products
Class I - Dangerous
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
Class I - Dangerous
UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Class I - Dangerous
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
Siemens Healthcare Diagnostics
Class I - Dangerous
Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.
Class I - Dangerous
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
Class I - Dangerous
Not approved labeling claims (antimicrobial and autolytic debridement)
Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Class I - Dangerous
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
CooperSurgical
Class I - Dangerous
Unsealed pouches.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.