FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc.: Acuject Variable Injection Needle
- Recall number
- Z-2089-2019
- Recalling firm
- Wilson-Cook Medical Inc.
- Product
- Acuject Variable Injection Needle
- Status
- Terminated
- Initiated
- 2019-06-14
- Posted
- not on file
- Terminated
- 2021-04-02
- Reason
- Potential for occluded injection needles.
- Root cause
- Employee error
- Action
- Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.
- Quantity
- 24
- Distribution
- Distributed to China
- Lot, serial or model codes
- Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079
- 510(k) numbers
- ["K941305"]
- PMA numbers
- not on file
- Product code
- FBK
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- 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