Medline Cardiac Surgery Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling cardiac surgery convenience kits because sterilization and packaging equipment calibration issues may have affected the sterility assurance level of the devices.
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 3/5 (High).
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: This is a Class II medical device recall with potential impact on sterility assurance of surgical kits. Although no reported illnesses are mentioned in the source, the risk involves high-risk sterile devices used in open-heart surgery where sterility failures could cause serious infection. This matches the rubric criterion for High (score 3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple models of Open Heart and Off Pump CABG (Coronary Artery Bypass Grafting) convenience kits. The company identified calibration issues with the equipment used to sterilize and package these devices.
Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level of the recalled products.
The recalled kits were distributed nationwide in the United States. A total of 51,061 units are affected across multiple model numbers and lot numbers. Consumers and healthcare facilities should stop using affected units and contact Medline Industries for instructions on returns or replacements.
Detailed product information, including specific model numbers and lot numbers, is available through the FDA's recall database.
The recalled product
- Product
- See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model…
- Manufacturer
- Medline Industries, LP
- Affected units
- 51,061
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) CDS840015AQ
- UDI-DI: 10195327210144(each)
- 40195327210145(case)
- Lot Number: 23FLA191
- 2) CDS840015AQ
- Lot Number: 24ILB176
- 3) CDS840023T
- UDI-DI: 10193489682069(each)
- 40193489682060(case)
- Lot Number: 21CKA394
- 4) CDS840023T
- Lot Number: 21EBN817
- 5) CDS840023T
- Lot Number: 21GBH886
- 6) CDS840023T
- Lot Number: 21IBG586
- 7) CDS840023T
- Lot Number: 21KBW667
- 8) CDS840023T
- Lot Number: 21LBV113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 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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