[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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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