Arrow International Inc: 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.

Agency Publication Date: February 25, 2019

Affected Products

Product: AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump

74A1801376 74G1702799 74A1801900 74H1700167 74A1802544 74H1701111 74B1700925 74H1701796 74C1701765 74H1702406 74D1700392 74J1700193 74D1701253 74J1700680 74D1701539 74J1701583 74D1702241 74J1702180 74E1700485 74J1702742 74E1701026 74K1700635 74E1701692 74K1701435 74E1702410 74K1702040 74F1700147 74K1702604 74F1701966 74L1700203 74F1702681 74L1700932 74F1703240 74L1702112 74G1700539 74M1700833 74G1701226 74M1701615

Product: AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74F1700085 74F1703357

Product: AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump

74A1801889 74H1700171 74F1700183 74H1701903 74F1701965 74H1703133 74F1702678 74K1700663

Product: AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump

74F1700794 74J1700676 74J1700190

Product: 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74A1801899 74H1602701 74B1700146 74L1700201 74B1700921

Product: AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump

74J1601025

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

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

Product: AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

74B1700141 74K1602023 74J1601147 74L1602735 74J1602863

Product: AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74A1700874 74G1702797 74F1700146 74H1701106 74F1701964

Product: AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74C1601434 74E1602096 74C1602395 74F1602444 74C1703028 74F1700186 74D1700428 74G1702048 74D1701032

Product: AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74B1602449

Product: AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump

74A1701382 74H1701147 74B1602450 74J1600057 74B1701726 74L1601123 74F1701975 74L1702110

Product: AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump

74A1600493 74E1701689 74A1701278 74F1601947 74B1700147 74G1601342 74B1700922 74H1601292 74C1601403 74H1602005 74C1601458 74J1601528 74C1601839 74K1601040 74C1602928 74K1601957 74C1702397 74L1601996 74D1600766 74L1602670 74E1600739 74M1501120 74E1601599 74M1600311 74E1700481 74M1600671

Product: AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump

74M1500647 74G1702789

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

74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1701946 74J1700678 74G1600394 74J1701748 74G1700546 74K1702039 74G1701177 74L1700931 74G1702054

Product: AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74H1701904

Product: AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

74E1702443

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81375

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 16 products (38; 8; 3; 5; 1; 8; 5; 5; 9; 1; 8; 26; 2; 19; 1; 1)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.