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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Arrow International Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0940-2019

Related Recalls

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

ARROW INTERNATIONAL

Class I - Dangerous

Reports have been received regarding open seals on the packaging.

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Apr 29, 2024 Surgical Instruments Nationwide View Details →

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Apr 29, 2024 Surgical Instruments Nationwide View Details →