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Terminated

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

FDA Recall Z-0490-2019 · Posted None

Recalling FirmMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Recall StatusTerminated
Product CodeFQH
Date Initiated2017-09-05
Date Terminated2024-09-23
Product Quantity10,440

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

Other

Distribution Pattern

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, PR, SC, TN, TX, UT, VA, VT, WA, and WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080779IRRISEPT WOUND CLEANSING SYSTEMIrrimax Corporation · 2009-02-04

Official Source

View FDA Recall →

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

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