Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate us

FDA device recall Z-2553-2011 · posted 2011-06-10 · Terminated

Recall details

Recalling firm

Medela Inc

Reason for recall

The product sterility may be compromised due to possible pinholes in the rigid tray of the package.

Action taken

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 and return the Product Inventory Form via fax to 800-995-7867 or email jim.hughes@medela.com, even if they have no affected product on hand 5)If you have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. Each affected product will be replaced with (2) non-sterile nipple shields. 5) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. Questions about the recall process were directed to Medela Customer Service at 1-888-835-5968 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.

Root cause

Packaging

Status

Terminated

Product code

HFS

Quantity affected

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.

Date initiated

2011-05-18

Date posted

2011-06-10

Date terminated

2012-02-16

Location

Mchenry, IL