FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: Thora-Para 8 Fr Catheter Drainage Tray
- Recall number
- Z-2653-2020
- Recalling firm
- Carefusion 2200 Inc
- Product
- Thora-Para 8 Fr Catheter Drainage Tray
- Status
- Terminated
- Initiated
- 2020-05-28
- Posted
- not on file
- Terminated
- 2024-09-20
- Reason
- The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- Root cause
- Under Investigation by firm
- Action
- All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.
- Quantity
- not on file
- Distribution
- 370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.
- Lot, serial or model codes
- Catalog: TPT1000 UDI: 50885403108486; Batches: 0001319053, 0001319438, 0001320227, 0001320514, 0001321276, 0001321497, 0001322638, 0001322905, 0001323536, 0001323775, 0001332576, 0001334403, 0001334406, 0001335268, 0001335696, 0001336965, 0001338449, 0001338788, 0001338789, 0001339414, 0001339562, 0001341206, 0001341633, 0001342263, 0001343223, 0001343636, 0001344137, 0001346668, 0001346670, 0001346671
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PXI
- Firm FEI
- 3008002452
- Firm city
- Vernon Hills
- Firm state
- IL
- 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