MedAmicus, Inc Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011
Brand
MedAmicus, Inc
Lot Codes / Batch Numbers
Lot Number W24540
Products Sold
Lot Number W24540
MedAmicus, Inc is recalling Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 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