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U.S. Department of Health and Human Services

Class 2 Device Recall BD Gravity IV Set

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  Class 2 Device Recall BD Gravity IV Set see related information
Date Initiated by Firm March 05, 2019
Create Date April 10, 2019
Recall Status1 Terminated 3 on July 15, 2020
Recall Number Z-1121-2019
Recall Event ID 82350
510(K)Number K931173  
Product Classification Set, administration, intravascular - Product Code FPA
Product Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Code Information 18105828 18105830 18105857 18105858
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Customer Advocacy
888-812-3266
Manufacturer Reason
for Recall		 The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 5, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that product was being recalled due to reports of kinked tubing which can lead to occlusion of the sets and reduction in the rate of infusion. Please Take the Following Actions: 1. Immediately review your inventory for the specific Catalogues (Ref) and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility 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 you have any of the impacted material, so that BD may acknowledge your receipt of this notification and provide product replacement. If you require further assistance, please contact: Customer Advocacy Phone: 888-812-3266 Phone hours: 24 hours a day, 7 days a week Email: customerfeedback@bd.com
Quantity in Commerce 21220 total cases of 20
Distribution Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.
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 = FPA and Original Applicant = IMED CORP.
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