FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
- Recall number
- Z-1946-2020
- Recalling firm
- Becton Dickinson & Company
- Product
- PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
- Status
- Terminated
- Initiated
- 2020-03-17
- Posted
- not on file
- Terminated
- 2020-10-21
- Reason
- Iincorrectly packaged without the required lidocaine as labeled
- Root cause
- Packaging change control
- Action
- BD issued Urgent Medical Device Recall letter issued on March 17, 2020 via Fed'x or email states reason for recall, health risk and action to take: 1.Examine your inventory of PowerGlide ST" Midline Catheter Maximal Barrier for product code ST018101D, Lot No. REDW0476. Inventory of this kit lot may be used by the clinician through alternate sourcing of lidocaine prior to initiating the procedure. Alternatively, any remaining inventory may be discarded. BD will provide you with a replacement for each kit discarded. 2.Share this recall notification with all users of the product within your facility to ensure they are also aware of this recall. 3.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse If you require further assistance, please contact: BD Contact Contact Information Customer/Technical Support Phone: 800-290-1689 Monday Friday between 8:00 am to 5:00 pm MST in the United States
- Quantity
- 655 kits
- Distribution
- AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
- Lot, serial or model codes
- Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390
- 510(k) numbers
- ["K170158"]
- PMA numbers
- not on file
- Product code
- PND
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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