| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | November 26, 2025 |
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| Date Posted | January 12, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1055-2026 |
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| Recall Event ID |
98154 |
| Product Classification |
General surgery tray - Product Code LRO
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| Product | Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B;
2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B;
3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C;
4) TOP DRAWER #6, Medline kit SKU ACC010688;
5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770;
6) SURGERY BAG, Medline kit SKU DYKM1279C;
7) ADMISSION KIT, Medline kit SKU DYKS1179;
8) PRE OP KIT, Medline kit SKU DYKS1192C;
9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B;
10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B;
11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248;
12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249;
13) PRE OP KIT, Medline kit SKU DYKS1274A;
14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324;
15) PRE OP KIT, Medline kit SKU DYKS1376;
16) PTC KIT, Medline kit SKU DYNDH1161A;
17) DR BROWN BODY, Medline kit SKU DYNJ910487. |
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| Code Information |
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB125;
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB400;
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25JDB835;
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA036;
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA248;
Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25IDA545;
Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25JDB867;
Medline kit SKU ACC010525C, UDI/DI 10198459027765 (EA) 40198459027766 (CS), Lot number 25KDA768;
Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25HDB656;
Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25IDA638;
Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25JDA666;
Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25HDA878;
Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA087;
Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA817;
Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25JDB317;
Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25IBL412;
Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25KBK165;
Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25IMD671;
Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25JMG868;
Medline kit SKU DYKS1192C, UDI/DI 10193489849707 (EA) 40193489849708 (CS), Lot number 25KME757;
Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25HBF059;
Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25JBU391;
Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25IBT744;
Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25KBG976;
Medline kit SKU DYKS1248, UDI/DI 10193489305708 (EA) 40193489305709 (CS), Lot number 25JBS281;
Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBJ008;
Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBV936;
Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25IBB540;
Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25HBF086;
Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25IBF923;
Medline kit SKU DYKS1324, UDI/DI 10193489969962 (EA) 40193489969963 (CS), Lot number 25IBR790;
Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25HBF087;
Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25IBS865;
Medline kit SKU DYNDH1161A, UDI/DI 10889942731299 (EA) 40889942731290 (CS), Lot number 25HBG750;
Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25GMK728;
Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25HMI417;
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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 recalls@medline.com. |
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| Quantity in Commerce | 3045 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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