Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP
Pending LLM rewrite. Source: FDA_DEVICE Z-1836-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The recalled product
- Product
- Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 60021775
- UDI-DI: 10193489041385(each)
- 20193489041382(case)
- Lot Number: 183372
- 2) 60021775
- Lot Number: 185190
- 3) 60022026
- UDI-DI: 10193489087253(each)
- 20193489087250(case)
- Lot Number: 106008
- 4) 60022026
- Lot Number: 117378
- 5) 60022673
- UDI-DI: 10193489041538(each)
- 20193489041535(case)
- Lot Number: 176180
- 6) 60030817
- UDI-DI: 10193489041972(each)
- 20193489041979(case)
- Lot Number: 185193
Distribution
Distributed nationwide across the United States.
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