Recall Z-1661-2012
MOOG Medical Devices Group · initiated May 18, 2012
Product
Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly, product code: 340-4126, Method of Sterilization using Ethylene Oxide. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Codes / lots: CF1130190, CF1200492, CF1200493, CF1202590, CF1202591, CF1206090, CF1206091.
Reason for recall
Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
FDA-determined cause: Process design
Action taken
The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Details
- Recall number
- Z-1661-2012
- Initiated
- May 18, 2012
- Posted by FDA
- May 30, 2012
- Terminated
- February 22, 2013
- Product code
- FPK – Tubing, Fluid Delivery
- Quantity
- 65,160
- Distribution
- Nationwide distribution: USA including states of: AZ, CA, FL, IL, KS, MA, MI, MD, NC, ND, NY, OK, OH, and TX.
- Recalling firm
- MOOG Medical Devices Group, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1659-2012 | Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly, product…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1660-2012 | Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1662-2012 | Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1663-2012 | Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1664-2012 | Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1665-2012 | Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1666-2012 | Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1667-2012 | Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1668-2012 | Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1669-2012 | Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code:…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1670-2012 | Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly, product…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1671-2012 | Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port…Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |
| Z-1672-2012 | Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly…Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment… | 05/18/2012Terminated |