FDAFDA · Food and drugs·Recall number Z-2228-2024
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.
Published July 10, 2024 · Recall initiated: March 14, 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
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
- Lot
- a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23DBK792, exp. 11/30/2027, UDI-DI each 10193489466812 and UDI-DI case-40193489466813. b. Pack #DYNJ56141A - lot numbers 23IBK595, exp. 1/31/2025, UDI-DI each-10193489555585 and UDI-DI case-40193489555586. c. Pack DYNJ62843A - lot numbers 24ABP043, exp. 12/31/2024, and 23IBM893, exp. 3/31/2025, UDI-DI each-10195327001766 and UDI-DI case-40195327001224. d. Pack #DYNJ63555C - lot numbers 24ALA613, exp. 3/31/2025; 23KLA748, 1/31/2025; 23KLA017, exp. 1/31/2025; 23JLA853, exp. 1/31/2025; 23JLA232. exp. 1/31/2025; 23ILB006, exp. 1/31/2025; 23ILA201, exp. 12/31/2024; and 23HLA429, exp. 12/31/2024; UDI-DI each-10193489816525 and UDI-DI case-40193489816526. e. Pack #DYNJ80649B - lot number 23JBG046, exp. 5/31/2026, UDI-DI each-10195327269944 and UDI-DI case-40195327269945.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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