5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Recall
- Recall Number
- Z-1991-2021
- Event Number
- 88048
- Firm
- Bard Access Systems Inc.
- FEI Number
- 3006260740
- Product Code
- LJS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 19, 2021
- Terminated
- January 24, 2023
- Address
- 605 N 5600 W, Salt Lake City, UT, 84116-3738
Description
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Catheter kits contained the incorrect micro-introducers.
On 05/19/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via FedEx second day air to customer informing them that they have confirm through customer complaints that catheter kits contains the incorrect micro-introducers. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and lot numbers and destroy all product subject to the recall following their institutions process for destruction. The Recalling Firm will replace discarded product. 2. Share this recall notification with all users within or outside their facility network to which they may have further distributed the affected products to ensure that 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 they have any of the impacted material so that Recalling Firm may acknowledge the receipt of this notification per FDA requirements and subsequently process your product replacement. For any questions or further assistance - contact: North American Regional Complaint Center 1-84BD-LIFE (1-844-823-5433) Say Recall when prompted MonFri 8:00am and 5:00pm CT
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
180 units