Medline Tissue Recovery Instrument Sets Recalled for Sterility Assurance Failure
Medline Industries is recalling Tissue Recovery Instrument Sets due to failure to meet sterility assurance levels. The instruments, used for tissue recovery in medical research and transplantation, were distributed in Wisconsin.
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: This is a Class II device used in high-risk medical applications including transplantation. The failure to meet sterility assurance standards creates a potential for serious harm through tissue contamination and transplant failure. No illnesses or injuries have been reported, making this a risk-of-harm situation without reported harm.
Plain-English summary
Medline Industries Inc is recalling Medline Tissue Recovery Instrument Sets (Reorder #DYNJ64347A), distributed in 36 three-kit cases containing 108 total kits. These are convenience kits used to recover tissue for medical research, education, or transplantation purposes.
The recalled devices may not meet the minimum required sterility assurance level. Tissue recovery instruments that do not maintain proper sterility pose a risk of contamination to recovered tissue, which could affect the safety of transplantation procedures or research applications.
The recalled products were distributed to Wisconsin. Affected lot numbers are 21CDA959, 21BDB665, 21ADA390, and 20KDC285. Healthcare facilities and research institutions that received these kits should discontinue use and contact Medline Industries Inc for instructions on return or replacement.
The recalled product
- Product
- Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
- Manufacturer
- Medline Industries Inc
- Hazard
- sterility-failure
- contamination-risk
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 (5)
- GTIN (01)10193489291186
- lot numbers 21CDA959
- 21BDB665
- 21ADA390
- and 20KDC285
Distribution
Distributed in 1 state:
- WI
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