Medline left heart kits recalled after 510(k) clearances were rescinded
Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall arising from a change in regulatory clearance status with no product defect or hazard described in the source, which fits the precautionary Moderate band.
Plain-English summary
Medline is recalling a range of custom procedure kits, including MTS LEFT HEART KIT-CAROLINAS HOS (model 60021775), DBD-MTS LHK BHS BAPTIST LOUISVILLE (60022026), MTO LEFT HEART KIT SUMMA BARBERTON (60022673), MTS LH KIT-UNIV OF MIAMI PG (60030817) and others listed in the recall notice. The action covers 19,189 units.
The recall is because the 510(k) regulatory clearances for certain control syringes, guidewires and/or high-pressure tubing contained in the kits have been rescinded. The FDA classified the action as Class II. The source does not describe any defect or hazard in the components themselves.
Distribution was nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the model numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by Medline.
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 — Procedure kit
- Affected units
- 19,189
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.
Part of a larger recall action
This product is one of 22 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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