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Terminated

Labeling is as follows: Product Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or repacking.***1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***Quantity: 20 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''

FDA Recall Z-1079-05 · Posted 2005-08-03

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2005-06-27
Date Terminated2007-04-19
Product Quantity700 syringes

Reason for Recall

The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.

Firm Action

The firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.

Root Cause

Other

Distribution Pattern

TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS

Official Source

View FDA Recall →

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

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