Device recalls

Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model…

MEDLINE INDUSTRIES, LP - Northfield · Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere…

Open, ClassifiedUnder Investigation by firmZ-1183-2025
Open FDA's page for this record
Cfres ID
212283
Product res number
Z-1183-2025
Event date initiated
2025-01-09
Event date posted
2025-02-19
Recall status
Open, Classified
Res event number
96188
Product code
LRO
Product description
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Firm FEI number
1417592
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Address 1
3 Lakes Dr
City
Northfield
State
IL
Postal code
60093-2753
Additional info contact
Karin Johnson 866-359-1704
Root cause description
Under Investigation by firm
Product quantity
0 kits
Distribution pattern
US States: CA, NY
Code info

1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437

Reason for recall

Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/9/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 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. 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 the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-282-FGX1 Recall Code: Recall Code 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

K numbers
K213481
Harmonized identifiers (openFDA)
Device name
General Surgery Tray
Medical specialty description
General, Plastic Surgery
Regulation number
878.4370
Device class
2
K number
K883250, K971061, K894685, K925214, K934688, K931824, K930270, K871437, K932221, K970286, K890729, K932220, K842648, K910365, K932217, K882684, K922133, K934030, K934428, K931758, K914037, K925016, K885090, K941846, K925216, K963721, K936117, K931844, K884093, K892389, K935686, K874439, K952539, K963443, K926269, K934029, K893814, K881083, K871873, K212258 +70 more
Registration number
2000028362, 3011144486, 3041276890, 9616088, 3013298431, 3004122598, 9611024, 3005997949, 3015058854, 8030672, 1650907, 3006673317, 3014421917, 3002806603, 2029015, 3014925393, 3004361903, 1061124, 1055236, 3004362278, 8022032, 3019798849, 1610287, 3016761372, 3044906632, 3013421458, 3006400329, 3004111573, 3009750712, 3013466775, 3006271008, 1066741, 1420054, 2936485, 3015960676, 8030678, 3008403546, 3031841433, 3006191977, 3036002406 +125 more
FEI number
2000028362, 3011144486, 3041276890, 3008373372, 3013298431, 3004122598, 1000113384, 1000160458, 3005997949, 3002805559, 3015058854, 3014421917, 3002807170, 3002806603, 3014925393, 1000208624, 2523865, 3003094575, 3004361903, 3004362278, 3019798849, 1610287, 3016761372, 3932, 3044906632, 3003015552, 3013421458, 3003803331, 3006400329, 3004111573, 3009750712, 3013466775, 3006271008, 3001236905, 1420054, 1000117501, 2936485, 3015960676, 3008403546, 3031841433 +125 more
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