Medline Industries, LP: MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINO

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: 44656 units Lot/code info: Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24GMJ742; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24FMC978; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24CMA556; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24BMI027; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMF247; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMA807; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23IMF051; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23HMG141; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23EMF259; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23DMA689; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMF097; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMC699; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22LME333; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 4019

UPC codes

10193489773484, 40193489773485, 10198459256400, 40198459256401, 10198459076527, 40198459076528, 10195327009014, 40195327009015, 10198459287473, 40198459287474, 10888277949683, 40888277949684, 10195327531867, 40195327531868, 10195327132187, 40195327132188, 10193489464672, 40193489464673, 10193489921298, 40193489921299, 10193489921366, 40193489921367, 10195327696917, 40195327696918, 10198459052613, 40198459052614, 10193489261974, 40193489261975, 10195327689131, 40195327689132, 10195327126100, 40195327126101, 10198459288869, 40198459288860, 10195327418915, 40195327418916, 10195327221171, 40195327221172, 10193489302660, 40193489302661

Source

Official record: FDA (Device enforcement) ↗

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