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FDAMarch 21, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

What to do

FDA enforcement status: Ongoing

Brands named

roi consolidated service center cscroiroi consolidated

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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