FDA Medical Device Recalls (openFDA)
Quest Medical, Inc.: Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
- Recall number
- Z-2107-2020
- Recalling firm
- Quest Medical, Inc.
- Product
- Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
- Status
- Terminated
- Initiated
- 2019-12-17
- Posted
- not on file
- Terminated
- 2024-04-17
- Reason
- Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
- Root cause
- Under Investigation by firm
- Action
- Customers who received product/affected lot were to be contacted via letter, Urgent-Product Recall Notice, dated 12/6/2019 sent to customers via XXX. Customers were to review their inventory to see if they had products from the affected lot. If they did have these products they were to place the product in quarantine and contact Quest Medical, Inc. using a form included with the recall notification. It instructed customers to complete and return the enclosed response form to Tosan Onosode Regulatory Affairs Supervisor,Quest Medical, Inc.,One Allentown Parkway Allen, TX 75002-4211 USA, Email: tonosode@questmedical.com Fax: +1 469-795-2338, Phone: +1 800-627-0226 ext. 338 so that they can arrange to correct the labeling defect on these units. It further stated that If customers had any questions or concerns regarding this action, they should contact Tosan Onosode, Regulatory Affairs Supervisor, Recall Coordinator at 1-800-627-0226, ext. 338.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
- Lot, serial or model codes
- Lot Number: 059135
- 510(k) numbers
- ["K173716"]
- PMA numbers
- not on file
- Product code
- DTR
- Firm FEI
- 3001665800
- Firm city
- Allen
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28