Z-2553-2011

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

Name: Z-2553-2011 Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for...
Creator: Medela Inc
Published: 2011-05-18
License: https://open.fda.gov/license/

Medela AG / initiated 2011-05-18 / Terminated / root cause: packaging

FDA source

Medela Inc began a recall of Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while... on 2011-05-18. The reason FDA records is "The product sterility may be compromised due to possible pinholes in the rigid tray of the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2553-2011
Status: Terminated
Initiated: 2011-05-18
Posted: 2011-06-10
Terminated: 2012-02-16
Recalling firm: Medela AG
Product: 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. For use under professional care only while breastfeeding the baby.
Product code: HFS Shield, Nipple
Reason for recall: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Root cause tag: packaging
FDA 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 and return the Product Inventory Form via fax to 800-995-7867 or email [email protected], 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 [email protected]. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.
Quantity in commerce: 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.
Product codes and lots: article number 67203S, lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806.

Product code HFS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)