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Terminated

EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

FDA Recall Z-2051-2021 · Posted None

Recall StatusTerminated
Product CodeGCJ
Date Initiated2021-06-15
Date Terminated2024-01-12
Product Quantity4,752 units

Reason for Recall

There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

Firm 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 [email protected], 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.

Root Cause

Employee error

Distribution Pattern

United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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