Arrow International Inc: Medical Device Recall in 2019 - (Recall #: Z-0947-2019)

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 FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: March 6, 2019

Recall Number: Z-0947-2019

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: 5

Code Information:

74B1700141 74K1602023 74J1601147 74L1602735 74J1602863

Distribution Pattern:

Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated