Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
Open FDA's page for this record- Cfres ID
- 221698
- Product res number
- Z-3019-2026
- Event date initiated
- 2026-07-10
- Event date posted
- 2026-08-26
- Recall status
- Open, Classified
- Res event number
- 99507
- Product code
- OES
- Product description
- Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
- Firm FEI number
- 1417592
- Recalling firm
- Medline Industries, LP
- Address 1
- 3 Lakes Dr
- City
- Northfield
- State
- IL
- Postal code
- 60093-2753
- Additional info contact
- Haley Barclay 866359-633-5463
- Reason for recall
- Kits contain a potentially contaminated component which were recalled by the manufacturer
- Root cause description
- Process change control
- Product quantity
- 71 kits
- Distribution pattern
- US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
- Code info
1) Medline Kit SKU DYNJ909393A, UDI/DI 10195327613945 (each) 40195327613946 (case) Lot Number 25ILA297; 2) Medline Kit SKU DYNJ910295D, UDI/DI 10198459586477 (each) 40198459586478 (case), Lot Number 26CBT178.
- Action
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Harmonized identifiers (openFDA)
- Device name
- Cardiac Catheterization Kit
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1200
- Device class
- 2
- Registration number
- 1422634, 3004911384, 3004519921, 9680794, 3004111573, 9616099, 9616088, 1030451, 1047429, 1423395, 2029015, 3004122598, 3011137372, 1423537, 1016427, 1643817, 3007329020, 1061124, 1928237, 3015173212, 3005595283, 3005012805, 3045816907, 3008513424, 1824619, 3011144486, 3035642068, 1018470, 3010532612, 3009888344, 3045816902
- FEI number
- 3003528016, 3002902735, 3004911384, 1000514656, 3004111573, 1030451, 3000717925, 1047429, 1018470, 3004122598, 1016427, 1643817, 3007329020, 1928237, 3005747797, 3015173212, 3005595283, 3005012805, 1000160458, 3045816907, 3008513424, 1824619, 3011144486, 1000512168, 3003737899, 3035642068, 3005846326, 3001236905, 3010532612, 3009888344, 3045816902