FDA Medical Device Recalls (openFDA)
Queen Comfort Products lLC: COVENA PICC Sleeve
- Recall number
- Z-0187-2022
- Recalling firm
- Queen Comfort Products lLC
- Product
- COVENA PICC Sleeve
- Status
- Terminated
- Initiated
- 2021-08-18
- Posted
- not on file
- Terminated
- 2024-05-06
- Reason
- Marketed without FDA clearance
- 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
- 91 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMQ
- Firm FEI
- 3018939295
- Firm city
- Waxhaw
- Firm state
- NC
- 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