FDAFDA · Food and drugs·Recall number Z-0533-2025
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Published December 4, 2024 · Recall initiated: October 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
- Lot
- (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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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