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FDA (Device enforcement)Recalled 2024-10-15class ii

MEDLINE INDUSTRIES, LP - Northfield: (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.

Hazard

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Details from the source

Reason for recall: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Distribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA. Quantity: 360 kits Lot/code info: (1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.

UPC codes

10193489573480, 40193489573481, 10195327362300, 40195327362301

Source

Official record: FDA (Device enforcement)

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

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