—#168404

Product

AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, 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: 74A1701422 74G1702788 74B1700142 74M1600770 74C1701810 74M1601742 74G1702049 74M1602233

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 #168404. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.