Recall Z-1185-2023— Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Corporation, initiated 2023-01-25. It names one FDA 510(k) clearance: K142801. 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.. Reason: 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..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-25
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.