Medtronic Disposable Pressure Display Sets recalled for unsealed sterile packaging
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.
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 recall scores High (3) because it involves a risk-of-harm medical device with potential for sterility compromise, but no illnesses or injuries have been reported. The FDA Class II designation indicates the defect requires correction; however, the theoretical nature of the hazard and absence of reported adverse events place it at Score 3 rather than higher.
Plain-English summary
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing.
Unsealed sterile packing may compromise the sterility of the medical devices. No illnesses or injuries have been reported in connection with this recall.
Affected lot numbers are listed in the FDA recall notice. Healthcare providers and consumers with these products should contact Medtronic Perfusion Systems for guidance on device replacement or return.
The recalled product
- Product
- Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Hazard
- unsealed-packaging
- sterility-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 (17)
- a) Model Number 61000
- GTIN 00643169880955
- Lot Numbers: 2023030432
- 2023030433
- GTIN 20643169880959
- Lot Numbers: 2023030431
- 2023030432
- 2023030734
- 202305C226
- 202307C176
- 202307C177
- b) Model Number 62000
- GTIN 20613994846642
- Lot Numbers: 2023030223
- 2023030736
- 2023031580
- 202305C225
Distribution
Distribution scope not specified by the agency.
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