Medivac Guardian blood loss estimation device inserts may provide inaccurate readings
Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.
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 a risk-of-harm product—inaccurate blood loss estimates could delay critical treatment recognition. No reported illnesses, injuries, or deaths are documented. Per the rubric, risk-of-harm products without reported incidents score 3 (High).
Plain-English summary
Stryker Corporation is recalling Finished Goods Boxes containing 50 inserts and scanning labels for the Medivac Guardian 3L blood loss estimation device. The affected product has Catalog Number FG 12022, and 541 units have been distributed nationwide.
The device may produce inaccurate blood loss estimates. These inaccurate readings could lead to confusion and potentially result in delayed recognition of postpartum hemorrhage (PPH), prolongation of PPH, or requirement for more aggressive treatment of PPH.
Healthcare providers using the Medivac Guardian 3L should verify whether they have devices with the affected lot numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, and M2206002. Contact Stryker Corporation with questions about the recall.
The recalled product
- Product
- Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
- Manufacturer
- Stryker Corporation
- Hazard
- inaccurate-readings
- delayed-recognition
- hemorrhage-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 (7)
- UDI-DI: 10859506006101 Lot Numbers: M2112001
- M2112003
- M2202001
- M2203001
- M2204001
- M2205001
- M2206002
Distribution
Distributed nationwide across the United States.
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