Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement
Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.
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 where the recalled components may output inaccurate measurements affecting clinical decision-making for postpartum hemorrhage management. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
Stryker Corporation is recalling Finished Goods Boxes of 50 inserts and scanning labels for the Medivac Guardian 2L medical device (Catalog Number FG 12010). This device is used as an adjunct tool for estimating blood loss during medical procedures. The recall affects 101 units with nationwide U.S. distribution.
The recalled inserts and scanning labels may cause the device to output inaccurate blood loss estimates. Inaccurate estimates could lead to confusion and potentially result in delayed recognition of postpartum hemorrhage, prolongation of postpartum hemorrhage treatment, or require more aggressive treatment than clinically appropriate.
Healthcare facilities and medical professionals using affected lot numbers (M2110004, M2201002, M2202001, M2203002, M2206001) should stop using the recalled inserts and labels. Contact Stryker Corporation for instructions on replacement or return of affected units.
The recalled product
- Product
- Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
- Manufacturer
- Stryker Corporation
- Hazard
- measurement-inaccuracy
- delayed-treatment-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)
- UDI-DI: 10859506006125 Lot Numbers: M2110004
- M2201002
- M2202001
- M2203002
- M2206001
Distribution
Distributed nationwide across the United States.
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