Z-1363-2025Class II

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS...

Name: Z-1363-2025 Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-13 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS... on 2025-02-13. FDA classified it as Class II and gives the reason as "Potential breach in pouch packaging which could lead to loss of sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1363-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-13
Posted: 2025-03-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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 [email protected].
Quantity in commerce: 1,482 units
Distribution: US Nationwide distribution.
Product codes and lots: Item No. 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 No. 45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1364-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1365-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1366-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1367-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1368-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1369-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14
Z-1370-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-14

Product code PUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)