Z-0187-2022Class II

COVENA PICC Sleeve

Name: Z-0187-2022 COVENA PICC Sleeve
Creator: Queen Comfort Products lLC
Published: 2021-08-18
License: https://open.fda.gov/license/

Queen Comfort Products LLC / initiated 2021-08-18 / Terminated / root cause: manufacturing process

FDA source

Queen Comfort Products lLC began a recall of COVENA PICC Sleeve on 2021-08-18. FDA classified it as Class II and gives the reason as "Marketed without FDA clearance". 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-0187-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-18
Posted: 2021-11-01
Terminated: 2024-05-06
Recalling firm: Queen Comfort Products LLC
Product: COVENA PICC Sleeve
Product code: FMQ Restraint, Protective
Reason for recall: Marketed without FDA clearance
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified their consignees of the recall through a distributor electronic portal on 08/17/2021. The firm requested return of the product.
Quantity in commerce: 91 units
Distribution: US Nationwide distribution.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0187-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0187-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-01

Product code FMQ

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)