Recall Z-2553-2011 ยท HFS Shield, Nipple
Medela Inc
Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone.
| Date | Jun 10, 2011 (initiated May 18, 2011) |
| Status | Terminated |
| Reason | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| Root cause | Packaging |
| Action | The firm, Medela, sent an "Important Device Recall" letter dated May 9, 2011 to all of their customers/direct accounts. Medala also began telephoning or visiting the direct accounts/customers on May 18, 2011. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lots and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form inlcude with this letter 4) complete |
| Quantity | 4,320 units |
| Distribution | Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.