FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790
- Recall number
- Z-2159-2010
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790
- Status
- Terminated
- Initiated
- 2010-06-08
- Posted
- 2010-08-02
- Terminated
- 2012-05-07
- Reason
- Vent port may be occluded and prevent delivery of fluid
- Root cause
- Equipment maintenance
- Action
- Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
- Quantity
- 58 packs
- Distribution
- Distribution USA and Canada
- Lot, serial or model codes
- Lots: ME19, MF10
- 510(k) numbers
- ["K823451"]
- PMA numbers
- not on file
- Product code
- DTR
- Firm FEI
- 1000149028
- Firm city
- Ashland
- Firm state
- MA
- 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