FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
- Recall number
- Z-0582-2020
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
- Status
- Open, Classified
- Initiated
- 2019-02-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Complaints received that products packaged with the incorrect introducer sheath size.
- Root cause
- Process control
- Action
- 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 BPV.CustomerSupportCenter@crbard.com. 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 BPV.CustomerSupportCenter@crbard.com 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
- Quantity
- 900 units
- Distribution
- US - Nationwide OUS - None
- Lot, serial or model codes
- Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407
- 510(k) numbers
- ["K063377"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28