Update on Alert: Fluid Delivery Set Issue from Medline
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed.
Affected Product
The FDA is aware that Medline has issued a letter to affected health care providers recommending certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits be removed from use.
| Medline Item Number | Description | Lot Number | UDI (each) | UDI (case) |
|---|---|---|---|---|
| 99000069 | FDS, 135, CHMN, W/F, MLL, RC(2), PG | 0000128741 | 10193489069587 | 30193489069581 |
| 99000069 | FDS, 135, CHMN, W/F, MLL, RC(2), PG | 0000134505 | 10193489069587 | 30193489069581 |
| 99000069 | FDS, 135, CHMN, W/F, MLL, RC(2), PG | 0000133893 | 10193489069587 | 30193489069581 |
| 99000069 | FDS, 135, CHMN, W/F, MLL, RC(2), PG | 0000135769 | 10193489069587 | 30193489069581 |
| 99000069 | FDS, 135, CHMN, W/F, MLL, RC(2), PG | 0000139596 | 10193489069587 | 30193489069581 |
| 949000222 | FDS, 135, NV, MICRO-CHAMBER, W/FILTER, BLUE | 0000133018 | 10197344018550 | 30197344018554 |
| 949000224 | FDS, 135, NV, MICRO-CHAMBER, W/FILTER, GREEN | 0000136573 | 10197344018642 | 30197344018646 |
| 949000221 | FDS, 135, NV, MICRO-CHAMBER, W/FILTER, RED | 0000133036 | 10197344018567 | 30197344018561 |
| 949000223 | FDS, 135, NV, MICRO-CHAMBER, W/FILTER, YELLOW | 0000133031 | 10197344018543 | 30197344018547 |
| 60130527 | MTO, 135, YELLOW, MICRO, SPK-MAIMONIDES | 0000133032 | 10193489046465 | 20193489046462 |
| 65111341 | MTO, ANGIO, DOUBLE, SPIKE, KIT, KENNEDY HLTH | 0000129541 | 10193489061314 | 20193489061311 |
| 65111341 | MTO, ANGIO, DOUBLE, SPIKE, KIT, KENNEDY HLTH | 0000134701 | 10193489061314 | 20193489061311 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000129544 | 10193489063950 | 20193489063957 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000128715 | 10193489063950 | 20193489063957 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000133060 | 10193489063950 | 20193489063957 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000131657 | 10193489063950 | 20193489063957 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000135723 | 10193489063950 | 20193489063957 |
| 65232486 | MTO, ANGIO, SINGLE, SPIKE, KIT | 0000135294 | 10193489063950 | 20193489063957 |
| 65071193 | MTO, ANGIO, SINGLE, SPIKE, KIT, GOOD, SAM | 0000130171 | 10193489060904 | 20193489060901 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000135606 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000134729 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000137115 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000130833 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000131669 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000129513 | 10193489070224 | 20193489070221 |
| 600604422 | MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA | 0000128721 | 10193489070224 | 20193489070221 |
| 60100045 | MTO, NEURO, KIT, -, JERSEY, SHORE PG | 0000129523 | 10193489044928 | 30193489044922 |
| 60100045 | MTO, NEURO, KIT, -, JERSEY, SHORE PG | 0000132393 | 10193489044928 | 30193489044922 |
| 60100045 | MTO, NEURO, KIT, -, JERSEY, SHORE PG | 0000134940 | 10193489044928 | 30193489044922 |
| 60100045 | MTO, NEURO, KIT, -, JERSEY, SHORE PG | 0000144158 | 10193489044928 | 30193489044922 |
| 60100045 | MTO, NEURO, KIT, -, JERSEY, SHORE PG | 0000139082 | 10193489044928 | 30193489044922 |
| 650801715 | MTO, RADIOLOGY, KIT, HAMOT MED CEN | 0000130138 | 10193489075458 | 20193489075455 |
| 650801715 | MTO, RADIOLOGY, KIT, HAMOT MED CEN | 0000132350 | 10193489075458 | 20193489075455 |
| 650801715 | MTO, RADIOLOGY, KIT, HAMOT MED CEN | 0000135736 | 10193489075458 | 20193489075455 |
| 60232481 | MTS, 135, CDS, IV, TUBE-JEFFERSON UNIV. | 0000129534 | 10193489053326 | 30193489053320 |
| 60120583 | MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED | 0000133660 | 10193489045864 | 30193489045868 |
| 60120583 | MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED | 0000136501 | 10193489045864 | 30193489045868 |
| 60120583 | MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED | 0000131600 | 10193489045864 | 30193489045868 |
| 601403920 | MTS, ANGIO, NEURO, KIT, NORTH SHORE UNIV | 0000131376 | 10193489071498 | 30193489071492 |
| 601403920 | MTS, ANGIO, NEURO, KIT, NORTH SHORE UNIV | 0000130940 | 10193489071498 | 30193489071492 |
| 62140602 | MTS, CUST. FILTER-NEWYORK UNIVERSITY | 0000132222 | 10193489057805 | 30193489057809 |
| 62140602 | MTS, CUST. FILTER-NEWYORK UNIVERSITY | 0000141215 | 10193489057805 | 30193489057809 |
| 602301614 | MTS, INTERV, NEURO, KIT-WESTCHESTER, MC | 0000133659 | 10193489072754 | 30193489072758 |
| 6010771601 | MTS, NEU, NORTH SHORE HOSPITAL | 0000127859 | 10193489099843 | 30193489099847 |
| 600602914 | MTS, NEURO, KIT | 0000135717 | 10193489070170 | 30193489070174 |
| 600602914 | MTS, NEURO, KIT | 0000128447 | 10193489070170 | 30193489070174 |
| 601400111 | MTS, NEURO, KIT, 2, NEWENGLAND MED CTR | 0000133121 | 10193489071344 | 30193489071348 |
| 601400111 | MTS, NEURO, KIT, 2, NEWENGLAND MED CTR | 0000130573 | 10193489071344 | 30193489071348 |
| 600604423 | MTS, NEURO, KIT, YLW&RED, FLORIDA HOSP | 0000128607 | 10193489070231 | 30193489070235 |
| 600604423 | MTS, NEURO, KIT, YLW&RED, FLORIDA HOSP | 0000137751 | 10193489070231 | 30193489070235 |
| 60110552 | MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER | 0000131878 | 10193489045611 | 30193489045615 |
| 60110552 | MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER | 0000130577 | 10193489045611 | 30193489045615 |
| 60110552 | MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER | 0000138084 | 10193489045611 | 30193489045615 |
| 60150035 | MTS, NEURO, KIT-OVERLOOK HOSPITAL PG | 0000130187 | 10193489048292 | 30193489048296 |
| 60150035 | MTS, NEURO, KIT-OVERLOOK HOSPITAL PG | 0000131883 | 10193489048292 | 30193489048296 |
| 60150035 | MTS, NEURO, KIT-OVERLOOK HOSPITAL PG | 0000143095 | 10193489048292 | 30193489048296 |
| 60182723 | MTS, NEURO, SPIKE, KIT, CAPITAL HLTHSYS-FULD | 0000130988 | 10193489049817 | 30193489049811 |
| 602500214 | MTS, NEURO-RADIOLOGY, KIT-YALE-NEWHAVEN | 0000127874 | 10193489072815 | 30193489072819 |
| 601403921 | MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV | 0000131619 | 30193489071508 | 30193489071508 |
| 601403921 | MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV | 0000133025 | 30193489071508 | 30193489071508 |
| 601403921 | MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV | 0000136559 | 30193489071508 | 30193489071508 |
| 601305210 | MTS, YELLOW, /, RED, MULTILINE, KIT, MAIMONIDE | 0000130984 | 10193489070989 | 30193489070983 |
| 601400110 | MTS, YELLOW, /, RED, MULTILINE, KIT, MAIMONIDE | 0000128757 | 10193489071337 | 30193489071331 |
What to Do
- On December 16, 2024, Medline sent all affected customers a Medical Device Recall letter recommending the following actions:
- Immediately check your stock for the affected item number and the affected lot numbers listed above.
- Confirm whether you received product with the incorrect white macro drip chamber. Fluid Delivery Sets with white macro drip chambers should be discarded. The image below shows the difference in drip chamber colors and should help in identifying impacted devices.
- If you have received the correct Fluid Delivery Set with a grey micro drip chamber, the product can be safely used.
Reason for Alert
Medline identified Fluid Delivery Sets that were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber. As a result, using a Fluid Delivery Set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling (edema), shortness of breath, increased blood pressure, and/or death.
Medline has not reported any injuries associated with this issue.
Device Use
These fluid delivery sets with drip chambers are provided as components convenience kits. Fluid delivery sets prevent air from entering into the IV tubing and regulate the solution's flow rate.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline’s Recall Department at recalls@medline.com or 866-359-1704.
Additional FDA Resources
- Early Alert: Fluid Delivery Set Issue from Medline [Archived] (12/30/2024)
- FDA's Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.