Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Reported: November 20, 2013 Initiated: August 29, 2013 #Z-0186-2014
Product Description
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Reason for Recall
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 508,029 cases
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 508,029 cases.
Why was this product recalled? ▼
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0186-2014.
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