Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provid
FDA device recall Z-0764-2013 · posted 2013-01-31 · Terminated
Recall details
- Recalling firm
- MOOG Medical Devices Group
- Reason for recall
- The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
- Action taken
- An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: himesstark@moog.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 92,488 units
- Distribution
- Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
- Date initiated
- 2012-10-12
- Date posted
- 2013-01-31
- Date terminated
- 2014-04-10
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENTERALITE INFINITY ENTERAL FEEDING PUMP (K031199) | Zevex Intl., Inc. | 2003-07-09 |