FDA Medical Device Recalls (openFDA)
ROi Consolidated Service Center (CSC): 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.
- Recall number
- Z-2221-2019
- Recalling firm
- ROi Consolidated Service Center (CSC)
- 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.
- Status
- Open, Classified
- Initiated
- 2019-03-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 312 packs
- Distribution
- Distributed to LA and MO
- Lot, serial or model codes
- Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- Firm FEI
- 3004513970
- Firm city
- Springfield
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28