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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124280

4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Official recall number

Z-1184-2014

Evidence summary

Product code
JKA
Recall status
Terminated
Event initiated
November 22, 2013
Root cause
Component change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1184-2014