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Open, Classified

Namic FLUID DELIVERY SET, REF 91300040

FDA Recall Z-1807-2024 · Posted 2024-05-10

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2024-03-12
Product Quantity50 units

Reason for Recall

Products have a lack of sterility assurance.

Firm Action

Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K852140NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)North American Instrument Corp. · 1985-05-30

Official Source

View FDA Recall →

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

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