FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
- Recall number
- Z-2389-2019
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
- Status
- Terminated
- Initiated
- 2019-05-31
- Posted
- not on file
- Terminated
- 2022-05-17
- Reason
- The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- Root cause
- Nonconforming Material/Component
- Action
- Bard Peripheral Vascular, Inc. (BPV) mailed a recall letter on May 23, 2019 to each of the US consignees via FedEx with proof of delivery notification. BPV is also issuing customer notifications for product outside the US in accordance with regulations of each country in which the product was distributed. The recall letter asked consignees to do the following: 1. Do not use or further distribute any affected product. 2. Please check all inventory locations within your 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, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, 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 your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at BDPI.CustomerSupportCenter@bd.com. Once all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacemnt product for your returned product. 7. Email the completed Recall and Effectiveness Check Form to BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call the BPV Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing labe
- Quantity
- 104 units
- Distribution
- US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, Canada,
- Lot, serial or model codes
- Lot # RECW2372 Exp. 3/31/2020
- 510(k) numbers
- ["K051748"]
- PMA numbers
- not on file
- Product code
- MSD
- 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