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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 039 08 15 000
Date submitted: 8/12/2015
Manufacturer:Arrow International Inc
Device Type:ARROW® International PICC Kits with Peel-Away Sheath Component
Description:catheter peel-away component
Medical Device Identifier:Products : ASK‐02041‐SEH1, CA‐05052‐HP, CDC‐34052‐VPS, EU‐05552‐HPMSB, ASK‐04001‐DU4, CA‐05052‐HPX, CDC‐35041‐VPS, FR‐04041, ASK‐04052‐AC, CDC‐02041‐MK1A, CDC‐35052‐VPS, FR‐04041‐CF, ASK‐05041‐LM4, CDC‐04041‐HPK1A, CDC‐35541‐VPS, FR‐05041, ASK‐05052‐SFL, CDC‐04052‐HPK1A, CDC‐35552‐VPS, FR‐05041‐CF, ASK‐05541‐MS2, CDC‐05041‐HPK1A, EU‐04041‐HP, FR‐05541‐CF, ASK‐05541‐MS3, CDC‐05052‐HPK1A, EU‐04041‐HPMSB, PI‐01451‐LS, ASK‐15552‐LM2, CDC‐05541‐HPK1A, EU‐04052‐HPMSB, PI‐01451‐LS5, ASK‐15552‐MS3, CDC‐05542‐PK1A, EU‐05041‐HPMSB, PK‐01451‐WS, ASK‐35041‐JHVA, CDC‐05552‐HPK1A, EU‐05052‐HPMSB, PK‐01451‐WSSP, CA‐05041‐HP, CDC‐15552‐HPK1A, EU‐05541‐HP, UK‐05041‐HPMIN, CA‐05041‐HPX, CDC‐34041‐VPS, EU‐05541‐HPMSB

Lot Numbers: Refer to Appendix 2
Reason of Field Safety Corrective Action:Arrow is recalling certain lots of the products referenced above due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
Remedy Action:We request that you check your inventory for product within the scope of this field action.

Users should cease use and distribution of stock of affected product and quarantine immediately.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:A5349FE03328B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Arrow.pdf