Date Initiated by Firm |
January 25, 2023 |
Date Posted |
February 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1184-2023 |
Recall Event ID |
91578 |
510(K)Number |
K142801
|
Product Classification |
Image processing device for estimation of external blood loss - Product Code PBZ
|
Product |
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. |
Code Information |
UDI-DI: 10859506006125
Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001 |
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 |
101 units |
Distribution |
US Nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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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