Recalls / —
—#180422
Product
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
- FDA product code
- PND — Midline Catheter
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K170158
- Affected lot / code info
- Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390
Why it was recalled
Iincorrectly packaged without the required lidocaine as labeled
Root cause (FDA determination)
Packaging change control
Action the firm took
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
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
Timeline
- Recall initiated
- 2020-03-17
- Terminated
- 2020-10-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #180422. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.