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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm January 25, 2023
Date Posted February 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-1186-2023
Recall Event ID 91578
510(K)Number K142801  
Product Classification Image processing device for estimation of external blood loss - Product Code PBZ
Product Triton Canister Software
Catalog Number: GAUS-2.

Intended adjunct in the estimation of blood loss.
Code Information UDI-DI: 00859506006029 Software Version: 2.8.4
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information Contact SAME
269-800-1941
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker issued Urgent Medical Device Correction letter to Risk Manager, OR Director, Materials Manager dated Jan 25, 2023. Letter states reason for recall, health risk and action to take: Steps: 1. Immediately check your internal inventory to locate any affected Finished Goods Inserts and Scanning labels (FG 12010 and FG 12022). Quarantine and discontinue use of all affected products. 2. A Stryker representative will contact your facility to assist updating the Triton Canister software. 3. Return the enclosed Business Reply Form (BRF) even if you don t have any affected product on hand, via email to instruments.recalls@stryker.com. 4. If the BRF indicates that recalled product is currently on hand, a shipping label will be provided to return recalled product. Upon receipt of the recalled product, Stryker will arrange replacements. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Contact: Sylvia Page | Stryker Instruments Recall Coordinator 269-501-8375 |Instruments.recalls@stryker.com
Quantity in Commerce 88 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PBZ and Original Applicant = Gauss Surgical, Inc.
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