Medline Neurosurgical Convenience Kits Sterilization Calibration Defect
Medline is recalling 52 models of neurosurgical convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
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 an FDA Class II medical device recall involving sterilization and packaging defects that could compromise sterility assurance—a significant quality control issue for surgical instruments used in high-risk procedures. The source text indicates no reported illnesses or injuries; the hazard is potential rather than realized, which per the rubric places it at 3 (High).
Plain-English summary
Medline Industries is recalling Medline Convenience Kits containing various neurosurgical components and equipment, including neuro shunt kits, neuro fusion kits, neuro decompressive cranio kits, neuro transphenoidal kits, and neuro packs. The recall includes 52 different model numbers, with a total of 10,184 units distributed nationwide and worldwide.
Medline identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to the validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
The products are distributed nationwide in the United States and worldwide. Affected healthcare facilities and users should stop using the recalled devices and contact Medline for instructions on return or replacement. Specific lot numbers are identified for each model number in the recall notice.
The recalled product
- Product
- Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
- Manufacturer
- Medline Industries, LP
- Hazard
- sterility-compromise
- calibration-defect
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) CDS860018G
- UDI-DI: 10889942459643(each)
- 40889942459644(case)
- Lot Number: 21CBA213
- 2) CDS860018G
- Lot Number: 21DBD719
- 3) CDS860018G
- Lot Number: 21GMA403
- 4) CDS860018G
- Lot Number: 21GME436
- 5) CDS860018G
- Lot Number: 21GMF497
- 6) CDS860018G
- Lot Number: 21JMH357
- 7) CDS860018G
- Lot Number: 21KMD971
- 8) CDS860018G
- Lot Number: 21LMG598
- 9) CDS860018G
- Lot Number: 22DMD555
Distribution
Distributed nationwide across the United States.