5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Numbe
Fresenius Medical Care Holdings, Inc.
The hazard
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Sets manufactured after February 26UPC 00840861102556UPC 00840861102563UPC 00840861102518UPC 00840861102532UPC 00840861102525Would you have heard about this one?
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