Arrow International Inc: Medical Device Recall in 2019 - (Recall #: Z-0946-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: March 6, 2019

Recall Number: Z-0946-2019

Event ID: 81375

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.

Status: Terminated

Product Quantity: 8

Code Information:

74A1701422 74G1702788 74B1700142 74M1600770 74C1701810 74M1601742 74G1702049 74M1602233

Distribution Pattern:

Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated