Z-2221-2019Class II

Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040...

Name: Z-2221-2019 Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040...
Creator: ROi Consolidated Service Center (CSC)
Published: 2019-03-21
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2019-03-21 / Open, Classified / root cause: manufacturing process

FDA source

ROi Consolidated Service Center (CSC) began a recall of Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690... on 2019-03-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2221-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-03-21
Posted: 2019-08-08
Recalling firm: Resource Optimization & Innovation, LLC
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.
Product code: KDD Kit, Surgical Instrument, Disposable
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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
Product codes and lots: Item Number (Lot Number, Expiration Date): 880341004 (043444D, 43566); 880341005 (047474E, 43706); 880341005 (049043E, 43750);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2221-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2220-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-14	2019-08-08
Z-2221-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)