Spire Biomedical, Inc. One Patriots Park 32CM ALTA EXCHANGE Model: AL27SH32 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
32CM ALTA EXCHANGE Model: AL27SH32 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free
Brand
Spire Biomedical, Inc. One Patriots Park
Lot Codes / Batch Numbers
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Products Sold
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Spire Biomedical, Inc. One Patriots Park is recalling 32CM ALTA EXCHANGE Model: AL27SH32 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip h due to There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinica. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
Recommended Action
Per FDA guidance
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026