Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Lot Codes / Batch Numbers
Lot 5689062
Products Sold
Lot 5689062
A medical device manufacturer is recalling Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Bal due to Some of the recalled catheters have a component that has levels of pyrogens above specification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the recalled catheters have a component that has levels of pyrogens above specification.
Recommended Action
Per FDA guidance
Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
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