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Terminated

8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter

FDA Recall Z-1271-2018 · Posted None

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJT
Date Initiated2017-11-22
Date Terminated2018-07-11
Product Quantity24 Eaches

Reason for Recall

The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

Firm Action

Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/

Root Cause

Mixed-up of materials/components

Distribution Pattern

CA, AR. AL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132177MEDCOMP GEN III POWER INJECTABLE PORTMedcomp ( Medical Components) · 2013-12-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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