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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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  Class 2 Device Recall Regard see related information
Date Initiated by Firm March 21, 2019
Create Date August 08, 2019
Recall Status1 Open3, Classified
Recall Number Z-2221-2019
Recall Event ID 82499
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product 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.
Code Information Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566);  880341005 (047474E, 43706); 880341005 (049043E, 43750);  
Recalling Firm/
Manufacturer		 ROi Consolidated Service Center (CSC)
2909 N Neergard Ave
Springfield MO 65803-6317
For Additional Information Contact Lacy Stewart
417-820-2793
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action ROi, Consolidated Service Center ROi, notified customers on about 03/21/2019. Each email included a copy of the ROi "MEDICAL DEVCIE RECALL NOTIFICATION" dated March 21, 2019 as well as the Stryker recall notification dated March 7, 2019. ROi notification letter instructed customers to review inventory to determine if the affected ROi Custom Pack item and lot numbers are in inventory, quarantine all affected packs on hand, and notify ROi of the number of each affected lot on hand by completing and returning "Attachment A" via email to lacy.stewart@roiscs.com. Supplemental labels for affected packs will be issued, which will instruct the end user to remove the affected Stryker component(s) and to use single sterile replacement product form inventory. If there is not any affected inventory on hand, customers are requested to still return Attachment A indicating "0" affected inventory at their facility.
Quantity in Commerce 312 packs
Distribution Distributed to LA and MO
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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