FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Cardiovascular Procedure Kit catalog # 76645 & 73806
- Recall number
- Z-0949-2022
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Cardiovascular Procedure Kit catalog # 76645 & 73806
- Status
- Terminated
- Initiated
- 2022-02-03
- Posted
- not on file
- Terminated
- 2024-02-20
- Reason
- Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
- Root cause
- Under Investigation by firm
- Action
- A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
- Quantity
- 64
- Distribution
- US Nationwide distribution in the states of CA and IN.
- Lot, serial or model codes
- [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- 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