FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
- Recall number
- Z-2051-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
- Status
- Terminated
- Initiated
- 2021-06-15
- Posted
- not on file
- Terminated
- 2024-01-12
- Reason
- There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
- Root cause
- Employee error
- Action
- On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
- Quantity
- 4,752 units
- Distribution
- United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
- Lot, serial or model codes
- Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.
- 510(k) numbers
- K193137
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- 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