Medline Industries, LP: MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ90809

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: 3521 units Lot/code info: Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBF166; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23DBM780; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22KBM832; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22JBY524; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22GBR089; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBR153; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBC633; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22EBB478; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBX706; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBU902; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22ABN864; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 21IBO640; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 401

UPC codes

10193489973846, 40193489973847, 10195327507077, 40195327507078, 10198459043499, 40198459043490, 10198459129773, 40198459129774, 10198459237782, 40198459237783, 10198459600197, 40198459600198, 10889942886418, 40889942886419, 10889942624065, 40889942624066, 10193489430615, 40193489430616, 10195327606169, 40195327606160, 10193489336238, 40193489336239, 10195327604967, 40195327604968

Source

Official record: FDA (Device enforcement) ↗

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