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U.S. Department of Health and Human Services

Class 2 Device Recall 5Fr PowerPICC Catheter SingleLumen with 70cm Guidewire

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  Class 2 Device Recall 5Fr PowerPICC Catheter SingleLumen with 70cm Guidewire see related information
Date Initiated by Firm May 19, 2021
Create Date June 30, 2021
Recall Status1 Terminated 3 on January 24, 2023
Recall Number Z-1991-2021
Recall Event ID 88048
510(K)Number K051672  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire

Instructions For Use:
PowerPicc Polyurethand Radiology PiCC with Microintroducer
Code Information Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Recalling Firm/
Manufacturer		 Bard Access Systems Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
844-823-5433
Manufacturer Reason
for Recall		 Catheter kits contained the incorrect micro-introducers.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 180 units
Distribution U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = BARD ACCESS SYSTEMS, INC.
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