Smiths Medical ASD Inc. PORT-A-CATH II POWER P.A.C. Low Profile" system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PORT-A-CATH II POWER P.A.C. Low Profile" system.
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
Lot 3921849.
Products Sold
Lot 3921849.
Smiths Medical ASD Inc. is recalling PORT-A-CATH II POWER P.A.C. Low Profile" system. due to Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter ins. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
Recommended Action
Per FDA guidance
Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter.
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
AR, CT, MS, TN, TX
Page updated: Jan 10, 2026