Z-1185-2023 Class II Ongoing
FDA device recall Z-1185-2023 was initiated by Stryker Corporation on January 25, 2023 and is designated Class II. 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 r… The recall status is ongoing. Affected quantity: 541 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- January 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 541 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 10859506006101 Lot Numbers: M2112001, M2112003, M2202001, M2203001, M2204001, M2205001, M2206002