—#187824

Product

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

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K193137
Affected lot / code info: Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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

Timeline

Recall initiated: 2021-06-15
Terminated: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.