AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall Z-0948-2019 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMEB
Date Initiated2018-10-02
Date Terminated2021-11-12
Product Quantity5
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.
Firm 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 [email protected]. 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.
Root Cause
Process control
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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