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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:201943

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;

Official recall number

Z-2337-2023

Evidence summary

Product code
OJK
Recall status
Open, Classified
Event initiated
May 15, 2023
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2337-2023

Field note

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