—#168420

Product

AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA product code: MEB — Pump, Infusion, Elastomeric
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090300
Affected lot / code info: 74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1701946 74J1700678 74G1600394 74J1701748 74G1700546 74K1702039 74G1701177 74L1700931 74G1702054

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2018-10-02
Terminated: 2021-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168420. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.