Reported Mar 8, 2023 · Ongoing
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- Finished Goods Box of 50 Inserts and Scanning Labels
- for Medivac Guardian 2L Catalog NumberFG 12010. Intended adjunct in the estimation of blood loss
- Lot codes and dates
- UDI-DI10859506006125
- Lot Numbers
M2110004M2201002M2202001M2203002M2206001
- Amount recalled
- 101 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
This product could cause temporary or reversible health problems — stop using it.
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