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

MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal Mtring, MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA: LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample

FDA Recall Z-0198-05 · Posted 2004-11-16

Recalling FirmMedex Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2004-10-20
Date Terminated2012-04-11
Product Quantity71,132 units.

Reason for Recall

Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.

Firm Action

The firm sent certified letters on October 20 & 21, 2004 to all customers to whom the product was sent directly and to all distributors to whom Medex shipped the product directly in the United States. Customers in foreign countries were notified via Fed Ex.

Root Cause

Other

Distribution Pattern

The product was distributed throughout the United States to distributors and hospitals located in FL, PA, CA, NE, SC, NY, MO, NM, GA, IL, MN, NC, Washington DC, RI, CO, MS, WI, HI, TX, MI, VA, WA, NJ, KY, MA, LA, TN, AZ, MD, OR, PR, UT, TN, OH, AL, IN, NV, OK and to foreign accounts located in Mexico, TMP, Ecuador, Brazil, LKA, Thailand, New Zealand, Australia, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902771ARTERIAL BLOOD SAMPLING KITMedex, Inc. · 1990-11-05

Official Source

View FDA Recall →

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

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