3 results
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89ms
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Sources: EU EUDAMED, US FDA
REGARD BOWL GUIDEWIRE
FDA Adverse Event
Malfunction
·ROI CONSOLIDATED SERVICE CENTER (CSC)·Product code OES·June 18, 2019
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019