Medline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration
Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
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 recall of medical devices (surgical kits) where sterilization integrity may be compromised. Potential loss of sterility on surgical instruments presents a risk of serious infection and injury to patients. The source text does not report any illnesses or injuries, but the hazard (compromised sterility of surgical devices) is high-risk and directly implies potential for serious patient harm.
Plain-English summary
Medline Industries, LP is recalling five models of arthroscopy convenience kits: ARTHROSCOPY CDS (Model CDS984609B), ARTHROSCOPY TRAYS (Model DYNJ22501G), ARTHROSCOPY PACK (Model DYNJ32715F), CHS ARTHROSCOPY PACK (Model DYNJ50834C), and ARTHROSCOPY TRAY-LF (Model DYNJ51069). The recall affects 175 units distributed nationwide in the United States.
The recall was initiated due to calibration issues identified in equipment used to sterilize and package the 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. Specific lot numbers are identified in the recall notice.
Patients or healthcare providers who have received these devices should contact Medline Industries, LP for further information and guidance regarding the recalled products.
The recalled product
- Product
- Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- surgical-device-contamination
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) CDS984609B
- UDI-DI: 10889942719372(each)
- 40889942719373(case)
- Lot Number: 21JBJ732
- 2) CDS984609B
- Lot Number: 22ABJ831
- 3) CDS984609B
- Lot Number: 22BBD031
- 4) CDS984609B
- Lot Number: 22FBP788
- 5) CDS984609B
- Lot Number: 22IBE795
- 6) CDS984609B
- Lot Number: 22IBF936
- 7) CDS984609B
- Lot Number: 23BBJ847
- 8) CDS984609B
- Lot Number: 23BBL738
- 9) DYNJ22501G
- UDI-DI: 10889942234110(each)
Distribution
Distributed nationwide across the United States.