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PowerPort M.R.I., ChronoFlex recallZ-0582-2020 · Bard Peripheral Vascular Inc · initiated Feb 14, 2019

Open, Classified

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 Bard Peripheral Vascular Inc 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

Complaints received that products packaged with the incorrect introducer sheath size.

FDA root cause category: Process control

What the company is doing

On 2/14/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via FedEx informing them the firm has identified one product code/lot number (RECS2407) may be at risk of incorrectly containing a 6.5Fr introducer sheath instead of an 8Fr introducer sheath. Customer are instructed to: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within their institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, and to immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to the Recalling Firm. 3. Remove any identified product from their shelves. 4. If the customers have used the affected product, to complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from customer inventory: 5. Fill out the Recall and Effectiveness Check Form and to be sure to state the quantities and lot numbers of each recalled product that is intended to be returned. It is extremely important that the Recalling Firm receive this information. 6. Please call Customer Support Center at 1-800-321-4254 Option #5 (M-F 6am to 3pm MST) or email at [email protected]. Once all information has been verified, Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. The Recalling Firm will issue a replacement product for its customer's returned product. 7. Email the completed Recall and Effectiveness Check Form to [email protected] or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing label will be enclosed for the custo

Recall details

Recall number
Z-0582-2020
Status
Open, Classified
Initiated by the company
Feb 14, 2019
Recalling firm
Bard Peripheral Vascular Inc
Quantity
900 units
Product code
LJT
FDA submissions
K063377
Distribution
US - Nationwide OUS - None

Product description

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Code information (models, lots, serial numbers)

Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407

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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