Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CADD Administration Sets, Model #21-7346-24

FDA Recall Z-0148-2022 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2020-07-14
Date Terminated2023-08-04
Product Quantity371 units

Reason for Recall

Product may have been manufactured with an air filter assembled in an incorrect orientation.

Firm Action

The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at [email protected].

Root Cause

Process control

Distribution Pattern

Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPDeltec, Inc. · 2003-05-23

Official Source

View FDA Recall →

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

↑