Date Initiated by Firm | October 02, 2018 |
Create Date | February 25, 2019 |
Recall Status1 |
Terminated 3 on November 12, 2021 |
Recall Number | Z-0956-2019 |
Recall Event ID |
81375 |
510(K)Number | K090300 |
Product Classification |
Pump, infusion, elastomeric - Product Code MEB
|
Product | AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump |
Code Information |
74E1702443 |
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 | 1 |
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
|