Medline Industries, LP: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit

Hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Details from the source

Reason for recall: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI. Quantity: 4801 units Lot/code info: Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22DBS093; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22CBJ072; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22BBX288; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21LBU240; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21JBP452; Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each), 40198459646103 (c

UPC codes

10195327013837, 40195327013838, 10198459646102, 40198459646103, 10889942885657, 40889942885658, 10198459085031, 40198459085032, 10198459159633, 40198459159634, 10195327203429, 40195327203420, 10195327690885, 40195327690886, 10193489952568, 40193489952569, 10193489997620, 40193489997621, 10889942046683, 40889942046684, 10198459154775, 40198459154776, 10198459389610, 40198459389611, 10195327136888, 40195327136889, 10198459660573, 40198459660574

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.