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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow AutoFuser Disposable Pain Control Pump

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  Class 2 Device Recall Arrow AutoFuser Disposable Pain Control Pump see related information
Date Initiated by Firm October 02, 2018
Create Date February 25, 2019
Recall Status1 Terminated 3 on November 12, 2021
Recall Number Z-0948-2019
Recall Event ID 81375
510(K)Number K090300  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Code Information 74A1700874 74G1702797 74F1700146 74H1701106 74F1701964
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall		 Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
FDA Determined
Cause 2		 Process control
Action On October 2, 2018, the firm notified consignees via an Urgent Medical Device Recall letter. The letter informed customers of the product issue. Customers were instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Teleflex Customer Service at 1-866-396-2111.
Quantity in Commerce 5
Distribution Nationwide distribution.
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 = MEB and Original Applicant = ACE MEDICAL US, LLC
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