Finished Goods Box of 50 Inserts and Scanning Labels recall: Software Issue
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood…
Why was Finished Goods Box of 50 Inserts and Scanning Labels 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10859506006101 Lot Numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, M2206002
- 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…
- Recalling firm
- Stryker Corporation
- Quantity
- 541 units
- Distribution
- US Nationwide distribution.
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)