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Z-2280-2019 Class II Terminated

Recalled by Codman & Shurtleff Inc — Fremont, CA

FDA device recall Z-2280-2019 was initiated by Codman & Shurtleff Inc on May 16, 2019 and is designated Class II. Reason for recall: Incorrect coil length on the label The recall status is terminated (terminated June 4, 2020). Affected quantity: 28 units.

Recall Details

Product Type
Devices
Report Date
August 21, 2019
Initiation Date
May 16, 2019
Termination Date
June 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units

Product Description

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

Reason for Recall

Incorrect coil length on the label

Distribution Pattern

Japan

Code Information

Lot/Serial No: L14364 UDI:10886704080138

Other recalls by Codman & Shurtleff Inc

  • Z-1572-2014 Class II — MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStr (November 10, 2015)
  • Z-1571-2014 Class II — MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStr (November 10, 2015)
  • Z-1684-2015 Class II — CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODM (March 5, 2015)
  • Z-0090-2015 Class II — Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Syste (September 15, 2014)
  • Z-0091-2015 Class II — Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) C (September 15, 2014)
  • Z-0089-2015 Class II — Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System (September 15, 2014)
  • Z-2191-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Cath (July 3, 2014)
  • Z-2189-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories (July 3, 2014)
  • Z-2184-2014 Class II — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas (July 3, 2014)
  • Z-2190-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessori (July 3, 2014)

FDA data resources