Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
Open FDA's page for this record- Cfres ID
- 222138
- Product res number
- Z-3121-2026
- Event date initiated
- 2026-08-11
- Event date posted
- 2026-09-14
- Recall status
- Open, Classified
- Res event number
- 99669
- Product code
- CAI
- Product description
- Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
- 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 866-359-1704
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 12 kits
- Distribution pattern
- US Nationwide distribution.
- Code info
1) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBH109; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBM182; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24HBS365
- Reason for recall
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
- Action
An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). 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. Upon completion of the below actions, please destroy 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 response form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX3 Recall Code: 3.Your account will receive credit once the response form is submitted. 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 request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Harmonized identifiers (openFDA)
- Device name
- Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5240
- Device class
- 1
- K number
- K910896, K926454, K911736, K953788, K944533, K840431, K932585, K870859, K932193, K841455, K811413, K942122, K861438, K925893, K932780, K881141, K854573, K924889, K932707, K911263, K942132, K871669, K932195, K822769, K896897, K932590, K833196, K770838, K853065, K770286, K852313, K833478, K931487, K942134, K942126, K912065, K890499, K832453, K952017, K871386 +144 more
- Registration number
- 3013412170, 1417592, 3007092328, 9616354, 3007997596, 3015495690, 3038195661, 2523320, 3004116032, 3009107690, 3013507143, 3015515504, 3012050423, 3011986317, 3001415205, 3006157842, 1314417, 3006783791, 3011185837, 3004111573, 1423395, 3010683054, 3004122598, 9610105, 3015168843, 9710391, 3004365956, 3006984712, 9710644, 3018762668, 3017828726, 3016458361, 3020777588, 1836161, 3015191173, 3015537026, 9681384, 3006897996, 3006547005, 2518157 +163 more
- FEI number
- 3013412170, 1417592, 3007092328, 3007997596, 3015495690, 3038195661, 2523320, 3004116032, 3009107690, 3013507143, 3015515504, 3012050423, 3011986317, 3001104093, 3001415205, 3002807626, 3002808440, 1314417, 3006783791, 3011185837, 3003244771, 3004111573, 3010683054, 3004122598, 3015168843, 3004365956, 3006984712, 3018762668, 3017828726, 3016458361, 3020777588, 3015191173, 3015537026, 3006897996, 3006547005, 2518157, 3005012805, 3003057578, 3016452400, 3016195240 +163 more
