Z-1050-2026Class II

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN...

Name: Z-1050-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN...
Creator: Medline Industries, LP
Published: 2025-11-26
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-11-26 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART... on 2025-11-26. FDA classified it as Class II and gives the reason as "Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1050-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-26
Posted: 2026-01-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 633 units
Distribution: US Nationwide distribution.
Product codes and lots: Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100; Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445; Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657; Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924; Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937; Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1050-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1049-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1050-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1051-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1052-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1053-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1054-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1055-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1056-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1057-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1058-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1059-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12
Z-1060-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12

Product code OEZ

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)