Z-1006-2022Class II

Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number...

Name: Z-1006-2022 Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number...
Creator: ROi CPS LLC
Published: 2022-03-18
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-03-18 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth on 2022-03-18. FDA classified it as Class II and gives the reason as "A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1006-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-18
Posted: 2022-04-26
Terminated: 2024-08-02
Recalling firm: ROi CPS LLC
Product: Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Product code: LRS I.V. Start Kit
Reason for recall: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm sent an email to the consignee on 3/18/2022 which said they have attached an Urgent Device Correction Notice for ROi CPS, LLC Convenience Kits that contain Regard branded IV Start Kits that were manufactured using PDI Prevantics products which were recalled by PDI. Attached to the email were the Urgent Device Correction notice dated 3/18/2022, a label template to be used to label the Regard IV start kits contained in the convenience kits, the original recall letter issued by PDI for their Prevantics products that were recalled, and a reply form. The Urgent Device Correction Notice dated 3/18/2022 explained the reason for the recall and listed the affected kit names and identification. The consignee was to review the inventory to determine if the affected kits were in inventory and to segregate and quarantine the kits noting that only the IV Start kit component within the kit was affected and all other items could be used. The customer was to use the attached label template to print warning labels to be affixed to the Regard IV Start Kits contained within the convenience kits. The label was to be applied to each IV Start Kit in a prominently visible location to end users of the kits and the location of the label should not cover any other critical product information found on the existing product label. The labels said 'URGENT PDI PREVANTICS DRUG RECALL DO NOT USE PREVANTICS SWABSTICK OR MAXI SWABSTICK IN THIS KIT PER THE PDI DRUG RECALL NOTICE DATED 2-4-2022 FORWARDED TO YOUR FACILITY." The consignee was to immediately notify any customers to whom the product was distributed or forwarded and the recall notification from the recalling firm, the notice from PDI, and the label template could be forwarded, as well. A reply form was enclosed for completion to indicate response to the notice. The customer was to respond regarding the number of kits in inventory and that they have read and understood the attached notice, forwarded t
Quantity in commerce: 950 convenience kits
Distribution: US Nationwide distribution in the state of Missouri.
Product codes and lots: Lot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-26
Z-1005-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-26
Z-1006-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-26

Product code LRS

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)