Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 Frenc
FDA device recall Z-1922-2013 · posted 2013-08-06 · Terminated
Recall details
- Recalling firm
- Nestle HealthCare Nutrition
- Reason for recall
- Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
- Action taken
- Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form. For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FPD
- Quantity affected
- 37,310
- Distribution
- US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
- Date initiated
- 2013-07-24
- Date posted
- 2013-08-06
- Date terminated
- 2014-06-13
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NASOGASTRIC FEEDING TUBE KITS (K915439) | Sandoz Nutrition | 1992-02-25 |