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RecallWatchMedical Device Safety
Class IIOngoingZ-1363-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Mar 26, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

Lot / code information

Part / Item #
DYNJCDCSEC01, DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108
UDI
(case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576
UDI
(each): 10888277367678, 10080196739493, 10080196778362, 10080196744220, 10080196287307, 10080196770038, 10080196164943, 10888277668843, 10080196574124, 10080196771110, 10080196292431, 10080196152575
Lot #
45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F — +10 moreShow all
45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185

What the firm is doing

Medline distributed an IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification, dated 2/13/25, to consignees who purchased individually packaged Proxima sterile surgical drapes and kits that contained Proxima sterile surgical drapes. Consignees that purchased kits containing recalled product are to immediately check stock for affected kits and place them in quarantine. Consignees are to complete the provided response form to receive over-labels to be applied to quarantined kits with additional instructions to remove the affected components prior to use of the kit. Consignees that purchased individual units of Proxima sterile surgical drapes are to immediately check stock for affected devices and immediately destroy identified product. Consignees are to complete the provided response form to obtain credit for the destroyed product. If a consignee is a distributor or have further distributed affected devices, they are instructed to forward the provided recall notification. Questions about this recall can be directed to Medline via phone at 866-359-1704 or by email to recalls@medline.com.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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