PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
This recall has been terminated (originally issued March 17, 2020).
- Company
- Becton Dickinson & Company
- Recall Initiated
- March 17, 2020
- Terminated
- October 21, 2020
- Recall Number
- Z-1946-2020
- Quantity
- 655 kits
- Firm Location
- Franklin Lakes, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Iincorrectly packaged without the required lidocaine as labeled
Distribution
AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
Lot / Code Info
Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390
Root Cause
Packaging change control
Action Taken
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