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Peripheral Catheter Insertion Kit recallZ-1946-2020 · Becton Dickinson & Company · initiated Mar 17, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Iincorrectly packaged without the required lidocaine as labeled

FDA root cause category: Packaging change control

What the company is doing

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

Recall details

Recall number
Z-1946-2020
Status
Terminated
Initiated by the company
Mar 17, 2020
Recalling firm
Becton Dickinson & Company
Quantity
655 kits
Product code
PND
FDA submissions
K170158
Distribution
AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),

Product description

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

Code information (models, lots, serial numbers)

Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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