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Terminated

Portex Unit Dose 5 ml Normal Saline (0.9%)

FDA Recall Z-0719-2019 · Posted 2019-02-04

Recalling FirmMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Recall StatusTerminated
Product CodeCAF
Date Initiated2017-09-05
Date Terminated2024-04-16
Product Quantity102,000

Reason for Recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Firm Action

Firm sent recall notification letters to customers on 9/5/2017.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K820227STER-O-DOSEInhalation Therapy Equipment, Co. · 1982-02-23

Official Source

View FDA Recall →

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

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