MedAmicus, Inc Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010
Brand
MedAmicus, Inc
Lot Codes / Batch Numbers
Lot Number W23155
Products Sold
Lot Number W23155
MedAmicus, Inc is recalling Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 due to Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
Recommended Action
Per FDA guidance
The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.
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 noticeDistribution
As reported by FDA
GA, IN, MO, NY, NC, OR
Page updated: Jan 10, 2026