FDA-Device2019-08-14Class II
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.
ROi Consolidated Service Center (CSC)
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.
Sold states
Distributed to LA and MO
Affected count
312 packs
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2019Don't want to check this manually?
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