RecallRadar

FDA Device recall Z-2499-2020

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system

On 2020-07-15 the FDA classified a Class II recall of PORT-A-CATH¿ II POWER P.A.C. Low Profile" system by Smiths Medical Asd, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2499-2020
ClassificationClass II
Statusterminated
Initiated2020-06-11
Published2020-07-15
Last updated2026-09-13 11:55 UTC
CompanySmiths Medical Asd
DistributionAR, CT, MS, TN, TX

Product

PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

Reason

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.

Identifiers

code_infoLot 3921849.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2499-2020%22

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