Z-1946-2020Class II

PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D

Name: Z-1946-2020 PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Creator: Becton Dickinson & Company
Published: 2020-03-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-03-17 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D on 2020-03-17. FDA classified it as Class II and gives the reason as "Iincorrectly packaged without the required lidocaine as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1946-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-17
Posted: 2020-05-09
Terminated: 2020-10-21
Recalling firm: Becton Dickinson & Co
Product: PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Product code: PND Midline Catheter
Reason for recall: Iincorrectly packaged without the required lidocaine as labeled
Root cause tag: packaging
FDA 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 in commerce: 655 kits
Distribution: AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
Product codes and lots: Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code PND

K170158Class IIPowerGlide ST Midline CatheterC.R. Bard, Inc. / cleared 2017-06-01

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)